Orion Oyj Class A · OMXHEX:ORNAV
Orion Oyj Class A — Orion Corp New B Shs — Q3 2023 Earnings Presentation
53 slides from Orion Oyj Class A's earnings presentation, Oct 26, 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
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) 6% 1% 9% 13% 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 2013 to 2022
Financial development from 2013 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 2014 2015 2016 2017 2018 2020 2021 2022 2
Slide 6: Outlook for 2023
Outlook for 2023 (specified on 17 July 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 p
Slide 7: 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 8: Growth drivers for Orion
Growth drivers for Orion 2022−2025 2025 → ODM-208* ODM-212* 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 8 Investor Pre
Slide 9: Key clinical development pipeline
Key clinical development pipeline Project/compound Indication PHASE I PHASE II PHASE III REGISTRATION ARANOTE / darolutamide 1 Prostate cancer (mHSPC) ARASTEP / darolutamide 1 Prostate cancer (BCR) ODM-208 2 Prostate cancer (mCRPC) ODM-105 / tasipimidine Insomnia ODM-111 (NaV 1.8 blocker) Pain ODM-2
Slide 10: 87,639 registered shareholders on 30 September 2023
87,639 registered shareholders on 30 September 2023 By number of shares By number of votes Households (Finnish retail) 5% 2% 5% 7% 7% 9% Non-Finnish holders and nominee-registered 39% 13% 7% Private corporations 62% Public sector 9% Non-profit institutions 34% Financial and insurance corporations 10
Slide 11: Largest shareholders by votes and shares on 30 September 2023
Largest shareholders by votes and shares on 30 September 2023 # Shareholder % of votes # Shareholder % of shares 1 Erkki Etola and companies 6.48% 1 Ilmarinen Mutual Pension Insurance Company 3.04% 2 Maa- ja vesitekniikan tuki r.y. and companies 5.37% 2 Varma Mutual Pension Insurance Company 2.83% 3
Slide 12: Orion B share performance January 2016 to September 2023
Share price, EUR 65 60 55 50 45 40 35 30 25 20 30-Jun-23 31-Mar-23 Orion B share price 31-Dec-22 30-Sep-22 30-Jun-22 31-Mar-22 31-Dec-21 30-Sep-21 OMXH-portfolio 30-Jun-21 31-Mar-21 31-Dec-20 from January 2016 to September 2023 30-Sep-20 30-Jun-20 Europe/Pharmaceutical 31-Mar-20 31-Dec-19 30-Sep-19
Slide 13: Highlights in January–September 2023
Highlights in January– September 2023 13 Investor Presentation © Orion Corporation
Slide 14: Key matters in Q3 2023
Key matters in Q3 2023 • Development was positive both in terms of net sales and operating profit excluding the significant upfront payment in the comparative period • Strong growth for Nubeqa® • EUR 30 million sales milestone from Nubeqa® recorded for Q3 • Easyhaler® product portfolio sales develop
Slide 15: January-September 2023: Underlying business performed well and mostly as expected
January-September 2023: Underlying business performed well and mostly as expected Cash flow from • Net sales in January–September 2023 Net sales operating activities • Includes EUR 30 million sales milestone from Nubeqa® per share • Exceptional comparative period due to significant ODM-208 related u
Slide 16: Net sales bridge from YTD9 2022 to YTD9 2023
Net sales bridge from YTD9 2022 to YTD9 2023 1 Dexmedetomidine for human use and Simdax® 5 Other products and services (excl. Animal Health and Fermion) 2 Nubeqa® (product sales and royalty) 6 Animal Health and Fermion 3 Entacapone products 7 Milestones 4 Russia 8 Exchange rates 16 Investor Presenta
Slide 17: Operating profit bridge YTD9 2022 to YTD9 2023
Operating profit bridge YTD9 2022 to YTD9 2023 1 Product & service sales without sales margin and product mix change and exchange rate effect 5 Milestones 2 Product sales margin and product mix change but without exchange rate effect 6 Other operating income and expenses 3 Exchange rate effect on gr
Slide 18: Business reviews
Business reviews 450.0 Sales split in YTD9 2023 400.0 350.0 6% 300.0 9% 19% 250.0 MEUR 200.0 150.0 22% 100.0 44% 50.0 0.0 Innovative Medicines -50.0 Branded Products Innovative Branded Generics & Animal Fermion Other* Generics and Consumer Health Medicines Products Consumer Health Animal Health Heal
Slide 19: TOP 10 products in YTD9 2023
TOP 10 products in YTD9 2023 EUR vs. Product or product portfolio million YTD9 2022 1. Nubeqa® 120.3 >100% 2. Easyhaler® product portfolio 101.6 +8.5% 3. Entacapone products1 67.7 -24.6% 4. Simdax® 20.2 -39.1% 5. Burana® 18.3 -5.2% 6. Dexdomitor®, Domitor®, Domosedan®, Antisedan® 18.2 -35.5% 7. Dexm
Slide 20: Innovative Medicines EUR 167.0 million (-42.5%)
Innovative Medicines EUR 167.0 million (-42.5%) – Nubeqa sales more than doubled • Decline due to significant EUR 228 million upfront Nubeqa® sales booked by Orion1 payment recorded in the comparative period 50 • Excluding the upfront payment, net sales more than 45 doubled 40 • Nubeqa® sales booked
Slide 21: Branded Products EUR 188.5 million (-10.7%)
Branded Products EUR 188.5 million (-10.7%) 120 • Easyhaler® product portfolio Sales split 101.6 continued on a solid growth 100 93.7 2% track 89.7 • The decline in entacapone 80 8% 67.7 mainly due to lower partner sales MEUR 60 • The decline in Divina® series 40 due to discontinuation of 36% 54% 20
Slide 22: Generics and Consumer Health EUR 383.6 million (-7.6%)
Generics and Consumer Health EUR 383.6 million (-7.6%) 350 • Generic competition pressing Sales split by geographic 312.0 the prices and sales of Simdax® 300 286.4 areas and dexmedetomidine products for human use 250 • Discontinuation of business 17% 200 operations in Russia also MEUR explains the n
Slide 23: Animal Health and Fermion
Animal Health and Fermion • Animal Health growth due to Animal Health Fermion acquisition of animal health 90 60 52.7 54.1 company VMD (Inovet) in June 80 77.1 2022 50 70 65.3 18.2 • However, in Q3 Animal Health 60 40 net sales declined from 50 28.3 comparative period due to MEUR 30 40 weakening dem
Slide 24: Orion is committed to maintaining biodiversity
Orion is committed to maintaining biodiversity – we are working to ensure that our business operations and value chain do not contribute to biodiversity loss ● We are actively seeking solutions to reduce the environmental impacts of the pharmaceutical industry in cooperation with other operators in
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 Immuno-Oncology Ion channels • FiCAR T-cell therapy • 2nd generation immune- Neuro-immune interaction 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 ARANOTE / darolutamide 1 Prostate cancer (mHSPC) ARASTEP / darolutamide 1 Prostate cancer (BCR) ODM-208 2 Prostate cancer (mCRPC) ODM-105 / tasipimidine Insomnia ODM-111 (NaV 1.8 blocker) Pain ODM-2
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
ODM-208 • ODM-208 is a CYP11A inhibitor blocking synthesis of • Partnering with Merck / MSD in 2022 steroids and thus ligands for androgen receptor • CYPIDES Ph II trial is on-going activation • Plan to proceed to Ph III studies by the end of 2023 Preliminary Phase II results – published at ESMO 202
Slide 34: ODM-208 suppressed steroid hormone biosynthesis and led to frequent PSA declines
ODM-208 suppressed steroid hormone biosynthesis and led to frequent PSA declines in men with extensively pre-treated mCRPC with AR-LBD mutations 53% (24/45) of patients achieved a serum PSA reduction Unmeasurable steroid hormone levels were achieved in of at least 50% from the baseline concentration
Slide 35: Sustainability is built into Orion's mission
Sustainability is built into Orion’s mission 35
Slide 36: 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 37: 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 38: Appendices
GRION Appendices
Slide 39: 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 2013 2012 2014 2015 2017 2018
Slide 40: 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 41: 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 42: 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 42 Investor Presentation © Orion Corporation
Slide 43: Key figures
Key figures 2019 2020 2021 2022 1-9/23 1-9/22 Change % Net sales, EUR million 1,051.0 1,078.1 1,041.0 1,340.6 868.5 1,046.1 -17.0% EBITDA, EUR million 308.9 336.5 289.1 487.1 220.4 433.9 -49.2% % of net sales 29.4% 31.2% 27.8% 36.3% 25.4% 41.5% Operating profit, EUR million 252.8 280.1 243.3 439.6 1
Slide 44: Income statement
Income statement EUR million 2019 2020 2021 2022 1-9/23 1-9/22 Change % Net sales 1,051.0 1,078.1 1,041.0 1,340.6 868.5 1,046.1 -17.0% Cost of goods sold -417.6 -434.4 -447.5 -489.0 -387.6 -350.6 +10.6% Gross profit 633.4 643.7 593.5 851.6 480.9 695.5 -30.9% Other operating income and expenses 2.2 5
Slide 45: 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 46: Financial position
Financial position EQUITY AND LIABILITIES ASSETS EUR million 9/23 9/22 Change % 12/22 EUR million 9/23 9/22 Change % 12/22 Share capital 92.2 92.2 92.2 Property, plant and equipment 392.1 364.6 +7.5% 373.3 Other reserves 3.3 3.3 +0.1% 3.3 Cumulative translation adjustments -10.8 -9.3 +16.6% -10.8 Go
Slide 47: Development of capital expenditure
Development of capital expenditure 250 200 150 EUR million 100 50 0 Property, plant and equipment Intangible assets VMD (Inovet) acquisition Depreciation, amortisation and impairment 47 Investor Presentation © Orion Corporation
Slide 48: Development of net working capital
Development of net working capital % of net sales EUR million 40% 500 30% 400 20% 300 200 10% 100 0% 0 -10% -100 -20% -200 -30% -300 Sep19 Sep16 Mar17 Sep17 Mar18 Sep18 Mar19 Mar20 Sep20 Mar21 Sep21 Mar22 Sep22 Mar23 Sep23 Jun16 Jun17 Jun18 Jun19 Jun21 Jun22 Jun23 Dec16 Dec17 Dec18 Dec19 Jun 20 Dec2
Slide 49: 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 50: Easyhaler® - One device with several therapy options for asthma or COPD
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 51: 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 and Innovative Medicines Branded Products Animal Health Fermion Consumer Health Key product switches Proprietary Innovative Proprietary Simda
Slide 52: 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 53: Upcoming events
Upcoming events Financial Statement Release for 2023 13/2/2024 AGM 2024 planned to be held on 20/3/2024 Interim Report 1–3/2024 25/4//2024 Half-Year Financial Report 1–6/2024 8/8/2024 Interim Report 1–9/2024 29/10/2024 53