Orion Oyj Class A · OMXHEX:ORNAV
Orion Oyj Class A — Orion Corp New B Shs — Q2 2023 Earnings Presentation
54 slides from Orion Oyj Class A's earnings presentation, Jul 17, 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 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 2015 2014 2015 2016 2017 2018 2020 2021 2
Slide 6: Outlook for 2023 (specified)
Outlook for 2023 (specified) 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
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 Milestones* COGS** Russia Simdax® and Milestones1 other declining Easyhaler® Pricing products pressure Russia 1 Excluding ODM-208 upfront payment * Excluding ODM-208
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-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 9 Investor Pre
Slide 10: 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 11: 83,339 registered shareholders on 30 June 2023
83,339 registered shareholders on 30 June 2023 By number of shares By number of votes Households (Finnish retail) 4% 2% 5% 7% 8% 7% Non-Finnish holders and nominee-registered 6% 39% Private corporations 13% 62% Public sector 9% Non-profit institutions 38% Financial and insurance corporations 11 Inve
Slide 12: Largest shareholders by votes and shares on 30 June 2023
Largest shareholders by votes and shares on 30 June 2023 # Shareholder % of votes # Shareholder % of shares 1 Erkki Etola and companies 6.48% 1 Ilmarinen Mutual Pension Insurance Company 2.68% 2 Maa- ja vesitekniikan tuki r.y. and companies 5.36% 2 Varma Mutual Pension Insurance Company 2.36% 3 Ilma
Slide 13: Orion B share performance from January 2016 to June 2023
Share price, EUR 65 60 55 50 45 40 35 30 25 20 30-Jun-23 31-Mar-23 31-Dec-22 Orion B share price 30-Sep-22 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 June 2023 30-Sep-19 30-Ju
Slide 14: Highlights in January–June 2023
Highlights in January–June 2023 14
Slide 15: Key matters in Q2 2023
Key matters in Q2 2023 • Orion has initiated a Phase II clinical trial with tasipimidine (ODM-105) for the treatment of insomnia • Orion is preparing to start a Phase I clinical trial with ODM-212 • Update to Easyhaler® product portfolio’s peak sales potential: Easyhaler has potential to exceed EUR
Slide 16: January-June 2023 mostly in line with our expectations
January-June 2023 mostly in line with our expectations Cash flow from • Net sales in H1 2023 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 pr
Slide 17: Net sales bridge from H1 2022 to H1 2023
Net sales bridge from H1 2022 to H1 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 Exchange rates 4 Russia 17 Investor Presentation © Orion Corp
Slide 18: Operating profit bridge H1 2022 to H1 2023
Operating profit bridge H1 2022 to H1 2023 ~EUR 21 million due to cost increase and changes in product mix ~EUR 36 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 Nubeqa product sa
Slide 19: Business reviews
Business reviews 300.0 Sales split in H1 2023 250.0 0% 6% 9% 17% 200.0 150.0 MEUR 22% 100.0 46% 50.0 0.0 Innovative Medicines Innovative Branded Generics & Animal Fermion Other* Branded Products Medicines Products Consumer Health Generics & Consumer Health -50.0 Health Animal Health Fermion H1 2022
Slide 20: TOP products in H1 2023
TOP 10 products in H1 2023 EUR vs. Product or product portfolio million H1 2022 1. Nubeqa® 83.0 +114.3% 2. Easyhaler® product portfolio 68.2 +4.9% 3. Entacapone products* 46.8 -27.3% 4. Simdax® 15.1 -38.2% 5. Dexdomitor®, Domitor®, Domosedan®, Antisedan® 12.8 -24.6% 6. Trexan® 12.6 +72.4% 7. Dexmede
Slide 21: Innovative Medicines EUR 94.2 million (+114.0%)
Innovative Medicines EUR 94.2 million (+114.0%) • Nubeqa® sales booked by Orion EUR 83.0 million Nubeqa® sales booked by Orion1 (+114.3%) in H1 2023 50 45 • Marinus received positive CHMP opinion recommending the approval of ganaxolone2 – 40 marketing authorisation expected in the coming 35 weeks 30
Slide 22: Branded Products EUR 126.8 million (-15.2%)
Branded Products EUR 126.8 million (-15.2%) 80 • Easyhaler® product portfolio Sales split 70 68.2 continued on a growth track 65.1 64.3 1% • The decline in entacapone 60 8% mainly due to lower partner 50 46.8 sales which is mainly explained by timing of partner deliveries MEUR 40 30 • The decline in
Slide 23: Generics and Consumer Health EUR 260.3 million (-7.8%)
Generics and Consumer Health EUR 260.3 million (-7.8%) 250 • Generic competition pressing Sales split by geographic the prices and sales of Simdax® 213.3 areas and dexmedetomidine products 195.1 200 for human use • Discontinuation of business 18% 150 operations in Russia also MEUR explains the net s
Slide 24: Animal Health and Fermion
Animal Health and Fermion • Animal Health growth due to Animal Health Fermion acquisition of animal health 60 60 company VMD (Inovet) in June 50.3 2022 50 50 12.8 • Sedatives remain the largest 40 40 36.1 37.3 product group in Animal Health 30.9 • Weakening demand in animal MEUR 30 30 health market
Slide 25: Outcome of Orion's double materiality assessment
The outcome of Orion’s double materiality assessment in accordance with Orion’s Sustainability Agenda Patient safety as a top priority Active work for a better Care for well-being Ethics at the core of our environment professionals business 1. Products that are effective, high-quality and safe to us
Slide 26: Research & Development
GRION Research & Development
Slide 27: Proprietary human pharmaceuticals developed by Orion
Proprietary human pharmaceuticals developed by Orion 27 Investor Presentation © Orion Corporation
Slide 28: Main Orion Animal Health Marketing Authorisations
Main Orion Animal Health Marketing Authorisations Geepenil Comforion Benzorion Kefavet 28 Investor Presentation © Orion Corporation
Slide 29: 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 30: 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 31: 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 31 Investor Presentation © Orion Corporation
Slide 32: 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 33: 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 34: 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 35: ODM-208 suppressed steroid hormone biosynthesis and led to 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 36: Sustainability is built into Orion's mission
Sustainability is built into Orion’s mission 36
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
GRION Appendices
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% 1.40 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 41: 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 42: 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 43: 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 43 Investor Presentation © Orion Corporation
Slide 44: Key figures
Key figures Change vs. Orion’s key figures 2019 2020 2021 2022 H1/23 H1/22 Net sales, EUR million 1,051.0 1,078.1 1,041.0 1,340.6 567.5 +2.4% EBITDA 308.9 336.5 289.1 487.1 126.9 -28.1% Operating profit, EUR million 252.8 280.1 243.3 439.6 102.0 -33.5% Profit before taxes, EUR million 250.8 278.3 24
Slide 45: Income statement
Income statement Change vs. Formation of profits, EUR million 2019 2020 2021 2022 H1/23 H1/22 Net sales 1,051.0 1,078.1 1,041.0 1,340.6 567.5 +2.4% Cost of goods sold -417.6 -434.4 -447.5 -489.0 -257.8 +19.9% Gross profit 633.4 643.7 593.5 851.6 309.6 -8.7% Other operating income and expenses 2.2 5.
Slide 46: 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 47: Financial position
Financial position EUR million 6/23 6/22 Change % EUR million 6/23 6/22 Change % Non-current assets total 632.5 646.0 -2.1% Inventories 350.9 316.8 +10.8% Equity total 768.0 749.9 +2.4% Interest-bearing non-current Trade receivables 185.3 187.1 -0.9% liabilities 183.2 203.3 -9.9% Other receivables 5
Slide 48: 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 48 Investor Presentation © Orion Corporation
Slide 49: 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 Dec22 Mar23 Jun16 Dec16 Jun17 Dec17 Jun18 Dec18 Jun19 Dec19 Dec20 Jun21 Dec21 Jun22 Jun23 Jun 20 Sep17 Sep16 Sep18 Sep19 Sep20 Se
Slide 50: 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 51: 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 52: 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 53: 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 54: Upcoming events
Upcoming events Interim Report 1–9/2023 26/10/2023 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 18/7/2024 Interim Report 1–9/2024 29/10/2024 54