Orion Oyj Class A · OMXHEX:ORNAV
Orion Oyj Class A — Orion Corp New B Shs — Q1 2023 Earnings Presentation
52 slides from Orion Oyj Class A's earnings presentation, May 9, 2023
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
GRION Orion in brief
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% 9% Operating profit EUR 440 million 9% 29% (EUR 232 million w/o ODM-208 upfront payment impact1) 10% Personnel 3,527 (31 Dec 2022) 25% R&D
Slide 5: 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 2019 2015 2014 2015 2016 2017 2018 2020 2021 2
Slide 6: 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 7: Basis for the outlook – key contributors
Basis for the outlook – key contributors Net sales Operating profit Nubeqa® Generic Nubeqa® Operating costs Animal Health competition COGS3 Milestones2 Milestones1 Russia Simdax® and other declining Easyhaler® Pricing products pressure 1 Excluding ODM-208 upfront payment 2 Excluding ODM-208 upfront
Slide 8: 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 9: 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 9 Investor Presentation
Slide 10: 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) ARASTEP / darolutamide 1 Prostate cancer (BCR) ODM-208 2 Prostate cancer (mCRPC) ODM-105 / tasipimid
Slide 11: 81,619 registered shareholders on 31 March 2023
81,619 registered shareholders on 31 March 2023 By number of shares By number of votes Households (Finnish retail) 3% 2% 5% 8% 8% 7% Non-Finnish holders and nominee-registered 6% 39% Private corporations 13% 61% Public sector 9% Non-profit institutions 39% Financial and insurance corporations 11 Inv
Slide 12: Largest shareholders by votes and shares on 31 March 2023
Largest shareholders by votes and shares on 31 March 2023 # Shareholder % of votes # Shareholder % of shares 1 Erkki Etola and companies 6.39 1 Ilmarinen Mutual Pension Insurance Company 2.68 2 Maa- ja vesitekniikan tuki r.y. and companies 5.29 2 Varma Mutual Pension Insurance Company 2.36 3 Ilmarin
Slide 13: Orion B share performance January 2016 to March 2023
Share price, EUR 65 60 55 50 45 40 35 30 25 20 31-Mar-23 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 OMXH-portfolio 31-Mar-21 31-Dec-20 30-Sep-20 30-Jun-20 31-Mar-20 Europe/Pharmaceutical 31-Dec-19 from January 2016 to March 2023 30-Sep-19 30-Jun-19 31-M
Slide 14: Highlights in January–March 2023
Highlights in January–March 2023
Slide 15: Nubeqa (darolutamide) is Orion's top selling product
Nubeqa®(darolutamide) is Orion’s top selling product • Nubeqa® Orion’s top-selling product in Q1’2023 • New clinical phase III trial ARASTEP • Approvals for additional indication (mHSPC) in Japan, European Union and China 15 Investor Presentation © Orion Corporation
Slide 16: Year started in line with our expectations
Year started in line with our expectations Cash flow from • Net sales Net sales operating activities • Main positives: Nubeqa® and Animal Health per share • Main negatives: entacapone, Russia, dexmedetomidine and Simdax MEUR EUR • Factors explaining the decline in operating profit 277.9 0.03 • Fixed
Slide 17: Net sales bridge Q1'2022 to Q1'2023
Net sales bridge Q1’2022 to Q1’2023 1 Nubeqa® (product sales & royalty) 5 Other products and services (ex Animal Health and Fermion) 2 Simdax® & dexmedetomidine for human use 6 Exchange rates 3 Entacapone products 7 Animal Health & Fermion 4 Russia 17 Investor Presentation © Orion Corporation The fi
Slide 18: Operating profit bridge Q1'2022 to Q1'2023
Operating profit bridge Q1’2022 to Q1’2023 ~EUR 10 million due to cost increase and changes in product mix ~EUR 17 million due to price decreases, of which significant part is explained by the fact that Orion supplied Nubeqa® to Bayer with lower price than in the comparative period 1 Product & servi
Slide 19: Business reviews
Business reviews 160 Sales split 140 -1% 120 7% 15% 100 10% 80 MEUR 21% 60 40 48% 20 0 Innovative Medicines Innovative Branded Generics & Animal Fermion Other* Branded Products -20 Medicines Products Consumer Health Generics & Consumer Health Health Animal Health Fermion 1-3/2022 1-3/2023 Other* 19
Slide 20: TOP products in Q1 2023
TOP 10 products in Q1 2023 EUR vs. Product or product portfolio million 1−3/2022 1. Nubeqa® 38.2 +93.0% 2. Easyhaler® product portfolio 32.2 +3.3% 3. Entacapone products* 21.5 -37.1% 4. Simdax® 8.1 -34.6% 5. Dexdomitor®, Domitor®, Domosedan®, Antisedan® 8.0 +41.8% 6. Trexan® (rheumatoid arthritis, c
Slide 21: Innovative Medicines EUR 41.8 million (+89.0%)
Innovative Medicines EUR 41.8 million (+89.0%) • Nubeqa® sales EUR 38.2 million (+93.0%) Nubeqa® sales booked by Orion* 45 40 35 30 25 MEUR 20 15 10 5 0 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2019 2020 2021 2022 2023 Product sales to Bayer Royalty *Orion’s sales to Bayer for commercial u
Slide 22: Branded Products EUR 59.5 million (-18.8%)
Branded Products EUR 59.5 million (-18.8%) 40 • Easyhaler® product portfolio Sales split 35 34.1 continued on a growth track 31.2 32.2 1% • The decline in entacapone 30 8% products mostly due to timing of 25 21.5 partner deliveries MEUR 20 • The decline in Divina® series 15 explained by contraction
Slide 23: Generics and Consumer Health EUR 133.7 million (-7.9%)
Generics and Consumer Health EUR 133.7 million (-7.9%) 120 • Generic competition pressing 109.7 Sales split by geographic the prices and sales of Simdax® 101.1 areas and dexmedetomidine products 100 for human use 80 • Contraction of business in Russia 21% also explaining the net sales MEUR 60 declin
Slide 24: Animal Health and Fermion
Animal Health and Fermion • Animal Health growth due to Animal Health Fermion acquisition of animal health 30 25 26.9 company VMD (Inovet) in June 25 20.2 2022 20 18.1 8.0 • Sedatives remain the largest 20 product group in Animal Health 15 • The decline in Fermion’s MEUR 15 13.2 reported external ne
Slide 25: Research & Development
GRION Research & Development
Slide 26: Proprietary human pharmaceuticals developed by Orion
Proprietary human pharmaceuticals developed by Orion 26 Investor Presentation © Orion Corporation
Slide 27: Main Orion Animal Health Marketing Authorisations
Main Orion Animal Health Marketing Authorisations Geepenil Comforion Benzorion Kefavet 27 Investor Presentation © Orion Corporation
Slide 28: 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 29: 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 30: 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 30 Investor Presentation © Orion Corporation
Slide 31: 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) ARASTEP / darolutamide 1 Prostate cancer (BCR) ODM-208 2 Prostate cancer (mCRPC) ODM-105 / tasipimid
Slide 32: 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 Overall survival prolongation by 22.0 months, 31% risk reduction (HR=0.69, p=0.003) 59% risk reduction
Slide 33: 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 34: Sustainability is built into Orion's mission
Sustainability is built into Orion’s mission
Slide 35: 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 36: 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 37: Appendices
GRION Appendices
Slide 38: 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% 1.40 1 400 400 1 200 25% 350 25% 1.20 20% 300 1.00 1 000 20% 15% 250 0.80 800 10% 200 15% 600 0.60 5% 150 10% 400 0.40 0% 100 5% 0.20 200 -5% 50 0 -10% 0 0% 0.00 2016* 2012 2013 2014 2015 201
Slide 39: Net sales and operating profit by quarter (MEUR)
Net sales and operating profit by quarter (MEUR) Net sales Operating profit 500 250 450 400 200 350 300 150 250 200 100 150 100 50 50 0 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 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 40 2022 271 284 492 295 202
Slide 40: Quarterly net sales by business division (MEUR)
Quarterly net sales by business division (MEUR) Innovative Medicines Branded Products Generics and Consumer Health 246.6 100 100 160 90 90 140 80 80 120 70 70 60 60 100 50 50 80 40 40 60 30 30 40 20 20 10 10 20 0 0 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2022 2023 2022 2023 2022 2023 Due to the change
Slide 41: Quarterly net sales by business division (MEUR)
Quarterly net sales by business division (MEUR) Animal Health Fermion 40 30 35 30 20 25 20 15 10 10 5 0 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2019 2020 2021 2022 2023 2019 2020 2021 2022 2023 41 Investor Presentation © Orion Corporation
Slide 42: Key figures
Key figures Change vs. Orion’s key figures 2019 2020 2021 2022 1-3/23 1-3/22 Net sales, EUR million 1,051.0 1,078.1 1,041.0 1,340.6 277.9 +2.7% EBITDA 308.9 336.5 289.1 487.1 67.7 -18.4% Operating profit, EUR million 252.8 280.1 243.3 439.6 55.5 -22.4% Profit before taxes, EUR million 250.8 278.3 24
Slide 43: Income statement
Income statement Change vs. Formation of profits, EUR million 2019 2020 2021 2022 1-3/23 1-3/22 Net sales 1,051.0 1,078.1 1,041.0 1,340.6 277.9 +2.7% Cost of goods sold -417.6 -434.4 -447.5 -491.7 -121.8 +15.5% Gross profit 633.4 643.7 593.5 851.6 156.1 -5.5% Other operating income and expenses 2.2
Slide 44: Royalties and milestones EUR million
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 45: Financial position
Financial position EUR million 3/23 3/22 Change % EUR million 3/23 3/22 Change % Non-current assets total 627.9 479.1 +31.0% Inventories 328.1 274.8 +19.4% Equity total 728.0 639.9 +13.8% Interest-bearing non-current Trade receivables 185.8 178.1 +4.3% liabilities 189.7 86.6 +119.0% Other receivable
Slide 46: Development of capital expenditure
Development of capital expenditure 250 200 150 EUR million 100 50 0 Property, plant and equipment Intangible assets VMD acquisition Depreciation, amortisation and impairment 46 Investor Presentation © Orion Corporation
Slide 47: 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 Dec20 Mar21 Mar22 Mar23 Dec15 Jun16 Dec16 Jun17 Dec17 Jun18 Dec18 Jun19 Dec19 Jun21 Dec21 Jun22 Dec22 Jun 20 Sep22 Sep16 Sep17 Sep18 Sep19 Se
Slide 48: 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 1.75 120% 0.20 0.12 1.50 0.
Slide 49: 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 50: New organisational structure as of 1 January 2023
New organisational structure as of 1 January 2023 Main changes Fermion & Contract Proprietary Products Specialty Products Animal Health Manufacturing Generics & Innovative Medicines Branded Products Animal Health Fermion Consumer Health Key product switches Proprietary Innovative Proprietary Simdax®
Slide 51: Quarterly net sales by unit (MEUR) – old business divisions
Quarterly net sales by unit (MEUR) – old business divisions 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 201
Slide 52: Upcoming events
Upcoming events Capital Markets Day 25/5/2023 Half-Year Financial Report 17/7/2023 Interim Report 1-9/2023 26/10/2023