Slide 1: Orion Financial Statement Release 2018
Orion Financial Statement Release 2018
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: Highlights in January–December 2018
Highlights in January–December 2018
Slide 4: Important year for future growth
Important year for future growth 1 2 Profitability was good, profit 2 The net sales of Proprietary margin for continuing Products increased slightly operations exceeded financial particularly due to strong target. Cash flow was strong. Easyhaler sales. Sales of Dexdor Net sales and operating profit
Slide 5: Key strategic target in 2019−2023: Growing more rapidly than the market
Key strategic target in 2019−2023: Growing more rapidly than the growth in the market 1 Net sales target Own investments in Investments in sales in 2025 new clinical trials: and marketing: E.g. strengthening 1.5 E.g. EUR 60 million investment in the Easyhaler Phase III trial on ALS product family (R
Slide 6: Key figures 1−12/2018 (continuing operations)
Key figures 1−12/2018 (continuing operations) Net sales Operating profit Operating Cash flow per share profit margin before financial items** 977 253 26% 2.32 MEUR (1,034) MEUR (284) (27%) EUR (1.09) -5% -11% +112% **) Cash flow per share before financial items: Continuing and discontinued operation
Slide 7: Net sales and operating profit development bridge
Without the negative impact of exchange rate changes and lower milestone payments and royalties, profitability would have slightly improved from 2017 Net sales, EUR million Operating profit, EUR million 1,034 31 19 13 284 10 22 16 12 1 5 19 23 977 253 54 60 37 37 33 (1) Product sales without sales m
Slide 8: Geographical breakdown and development of net sales
Geographical breakdown and development of net sales 1−12/2018 1−12/2017 1−12/2018 EUR million 15% -5% 350 -2% 6% 32% 300 250 -11% 200 +5% 31% 150 -26% 16% 100 Finland 50 Scandinavia Other Europe 0 North America Finland Scandinavia Other North Other Other markets Europe America markets Financial Stat
Slide 9: Net sales by business division
Net sales by business division EUR million 1−12/2018 -9% 600 5% 2% 519 473 8% 500 +2% 400 351 357 37% 300 200 +6% -1% -55% 48% 100 76 80 51 51 36 16 0 Proprietary Products Specialty Proprietary Animal Fermion Contract Specialty Products Products Products Health manufacturing Animal Health & other Fe
Slide 10: Best-selling pharmaceuticals 1−12/2018
Best-selling pharmaceuticals 1−12/2018 Net sales Change vs . Indication (EUR million) 1−12/2017 1. Parkinson’s disease 100 -3% 2. Asthma, COPD 90 +18% 3. Intensive care sedative 63 -2% 4. Acute heart failure 59 +4% 5. Animal sedatives 34 +10% 6. Intensive care sedative 26 +3% Rheumatoid arthritis, i
Slide 11: Proprietary Products
Proprietary Products
Slide 12: Proprietary Products
Proprietary Products Easyhaler Simdax ● Strong growth, investments in ● Sales increased slightly. sales and marketing Possible generic competition particularly in Germany. is not estimated to have a ● Salmeterol-fluticasone material impact on sales Easyhaler sales started. in 2019. Dexdor Parkinson’
Slide 13: Sales of Proprietary Products increased slightly
Sales of Proprietary Products increased slightly EUR 1−12/2018 million -3% 120 +18% 5% 104 100 7% 100 90 -2% 28% 77 +4% 17% 80 64 63 57 59 60 +3% 40 25 26 18% 25% 20 Parkinson: Stalevo, Comtess & Comtan 0 Easyhaler Parkinson’s Easyhaler Dexdor Simdax Precedex Dexdor drugs product Simdax family Prece
Slide 14: Decrease in sales of Parkinson's drugs slowed down
Decrease in sales of Parkinson’s drugs slowed down Sales of Orion’s branded Sales, EUR million Parkinson’s drugs by market area 50 45 40 2% 35 30 25 30% 20 35% 15 10 5 0 Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4 2014 2015 2016 2017 2018 Europe 33% Japan Deliveries of Parkinson’s drugs (Stalevo, ROW C
Slide 15: Repatriation of Stalevo's sales and distribution rights in Europe
Repatriation of Stalevo's sales and distribution rights in Europe reinforces Orion's growth targets ● The rights were transferred back from Novartis in December: – 18 EU countries and a few other European country. ● Added sales initially around EUR 20 million/year. ● Provides Orion with greater oppo
Slide 16: Easyhaler product family will be a key source of growth
Easyhaler product family will be a key source of growth in the next few years ● Continued strong growth for budesonide- Sales, EUR million formoterol Easyhaler. 30 ● Product family total sales: +18% 25 ● Budesonide-formoterol Easyhaler: +29% 20 – Strong market position in some markets, e.g. in Swede
Slide 17: Sales of Dexdor continued to grow in most European markets
Sales of Dexdor intensive care sedative continued to grow in most European markets – generic competition expected to expand in 2019 Total value of the European sedatives market: EUR 558 million Sales, EUR million 20 (+3%) 18 12% 16 14 12% 12 65% 10 8 11% 6 4 2 0 Propofol EUR 361 million (+4%) Q1 Q2
Slide 18: Specialty Products
Specialty Products GRION Building well-being
Slide 19: Specialty Products
Specialty Products ● Net sales of biosimilars decreased ● Net sales decreased in Finland from record year 2017. and Scandinavia, and grew in ● The decrease was due to tightened Eastern Europe and Russia. competition, declined price level and the situation of tendering competitions. ● Orion won the n
Slide 20: Specialty Products: tightened price competition and lower biosimilar sales
Specialty Products: tightened price competition and lower sales of biosimilars showed as a decrease in net sales Development of net sales Net sales by region Net sales by product EUR 1−12/2018 1−12/2018 million -7% 350 13% 5% 292 300 273 250 14% 58% 24% 71% 200 -26% 150 +2% 94 100 69 65 66 15% 50 0
Slide 21: In Finland, price competition has led to a decline in reference priced drugs
In Finland, price competition has led to a decline in the entire market of reference priced prescription drugs The market of reference priced The sales of Orion’s reference prescription drugs in Finland priced prescription drugs (1–12/2018) in Finland 490 126 MEUR (528) MEUR (139) Market development
Slide 22: Orion is Finland's most significant provider of pharmaceuticals
Orion is Finland's most significant provider of pharmaceuticals Human pharma market in Finland (1−12/2018) Reference Self-care Medicinal and non-medicinal products priced products in hospital and pharmacy channels: EUR 2,746 million prescription Orion market share EUR million drugs in pharmacy Orion
Slide 23: Research and development
Research and development
Slide 24: Orion's key clinical drug development projects
Orion’s key clinical drug development projects Project Indication Phase Registration Easyhaler® tiotropium COPD Bioequivalence study Darolutamide 1) Prostate cancer (nmCRPC) I II III Darolutamide 1) Prostate cancer (mHSPC) I II III ODM-109 (oral levosimendan) ALS I II III ODM-104 (more effective COM
Slide 25: Phase III trial of darolutamide for nmCRPC: primary endpoint met
Orion and Bayer’s phase III trial of darolutamide for non-metastatic castration-resistant prostate cancer: Primary endpoint was met ● Darolutamide significantly extended ● Bayer is having discussions with health metastasis-free survival compared to authorities regarding the submission for placebo. T
Slide 26: Financial impacts of darolutamide
Financial impacts of darolutamide ● Bayer covered the majority of the development costs and has the right to commercialize darolutamide globally. Orion has the option of co-promoting in Europe. Orion will manufacture the product. ● Milestone payments upon first commercial sales: EUR 45 million in th
Slide 27: ODM-109: Oral levosimendan for ALS
ODM-109: Oral levosimendan for ALS ● First patients recruited in July 2018 ● The aim is to apply for marketing authorisation for the Phase III clinical trial (REFALS). in the US and Europe. ● By enhancing respiratory muscle function ● Levosimendan has been granted an Orphan Drug in ALS patients, ora
Slide 28: ODM-109 (ALS): Phase III clinical trial REFALS recruiting
ODM-109 (ALS): Phase III clinical trial REFALS recruiting 450 patients Primary endpoints • Levosimendan • 12 weeks: 1-2mg/day Slow vital capacity (300 patients) (Breathing • Placebo capacity compared to normal subjects) (150 patients) • 48 weeks: ~100 clinical sites ALS functional rating scale (Over
Slide 29: Orion's key business targets in 2019
Orion's key business targets in 2019 1. Preparation for the commercialisation of 5. Accelerating the growth of darolutamide. ARASENS trial (metastatic the Easyhaler product family and prostate cancer) continues in order to strengthening its market position. expand the indication. Salmeterol-fluticas
Slide 30: Material themes of Orion's sustainability
Material themes of Orion’s sustainability • Patient safety • Ensuring reliable supply of medications • Manufacturing medications in an environmentally sustainable way: efficient use of materials, energy efficiency, wastewater management Customer Audits undertaken Energy Energy savings Injury rate co
Slide 31: Digital projects to improve patients' well-being
Digital projects to improve patients' well-being ● Daisy: Optimising Parkinson’s patient’s quality ON-time (when medication is effective, and symptoms are under control) by gathering data on the patient’s condition. ● Orion and ● ToxBuddy: Fifth Corner Inc: Information and The research project suppo
Slide 32: Outlook
Outlook
Slide 33: Investments in growth EUR 30 million in 2019
Investments in growth EUR 30 million in 2019 ● The ongoing projects ● This comprises clearly ● At the same time, operating supporting growth are increased depreciation as profit is burdened by expected to burden Orion’s well as investments in intense price competition in profit in 2019 by an sales a
Slide 34: Outlook for 2019
Outlook for 2019 Net sales Orion estimates that in 2019 net sales will be + slightly higher than in 2018 (net sales in 2018 were EUR 977 million). The estimated net sales include the possible EUR 45 million milestone payment associated with the commercialisation of darolutamide. Operating = profit O
Slide 35: Orion calendar
Orion calendar Financial Statements 2018 By week 10 Annual General Meeting 26/3/2019 Interim Report 1−3/2019 25/4/2019 Half-Year Financial Report 1−6/2019 17/7/2019 Interim Report 1−9/2019 23/10/2019 Capital Markets Day in Helsinki on 22/5/2019
Slide 36: Building well-being
Building well-being GRION Building well-being