Orion Oyj Class A · OMXHEX:ORNAV
Orion Oyj Class A — Q3 2018 Earnings Presentation
32 slides from Orion Oyj Class A's earnings presentation, Oct 24, 2018
Slide 1: Orion Interim Report 1−9/2018
Orion Interim Report 1−9/2018
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–September 2018
Highlights in January–September 2018
Slide 4: Orion and Bayer's Phase III trial of darolutamide met primary endpoint
Orion and Bayer's Phase III trial of prostate cancer drug darolutamide met primary endpoint 1 3 Darolutamide: Discussions Sales of Proprietary Products with authorities regarding were at level with comparative the submission for period. Net sales of Specialty marketing authorization Products continu
Slide 5: Key figures 1−9/2018 (continuing operations)
Key figures 1−9/2018 (continuing operations) Net sales Operating profit Operating profit Cash flow per share margin before financial items** 715 184 26% 2.10 MEUR (768) MEUR (214) (28%) EUR (0.86) -7% -14% +143% **) Cash flow per share before financial items: Continuing and discontinued operations I
Slide 6: Most of the profit decrease due to exchange rate changes and lower milestone payments
Most of the profit decrease due to exchange rate changes and lower milestone payments and royalties − Otherwise, profitability only slightly below comparative period Net sales, EUR million Operating profit, EUR million 214 16 768 25 10 12 15 9 11 1 4 9 8 184 715 48 46 37 37 34 34 (1) Biosimilars in
Slide 7: Geographical breakdown and development of net sales
Geographical breakdown and development of net sales 1−9/2018 1−9/2017 1−9/2018 EUR million 15% 300 -6% 32% -5% 6% 250 200 150 -13% -1% 31% 16% 100 -18% Finland 50 Scandinavia Other Europe 0 North America Finland Scandinavia Other North Other Other markets Europe America markets Interim Report 1–9/20
Slide 8: Net sales by business division
Net sales by business division EUR million 1−9/2018 -10% 450 5% 2% 400 387 347 0% 8% 350 300 261 261 36% 250 200 +4% 150 -7% -48% 49% 100 58 56 40 38 50 24 12 0 Proprietary Products Specialty Proprietary Animal Fermion Contract Specialty Products Products Products Health manufacturing Animal Health
Slide 9: Best-selling pharmaceuticals 1−9/2018
Best-selling pharmaceuticals 1−9/2018 Net sales Change vs . Indication (EUR million) 1−9/2017 1. Parkinson’s disease 76 -5% 2. Asthma, COPD 64 +17% 3. Intensive care sedative 48 +2% 4. Acute heart failure 43 +2% 5. Animal sedatives 23 +6% Rheumatoid arthritis, inflammatory 6. Biosimilars bowel disea
Slide 10: Proprietary Products
Proprietary Products
Slide 11: Proprietary Products
Proprietary Products Easyhaler Simdax ● Budesonide-formoterol Easyhaler ● Sales increased continued strong growth. slightly. ● First deliveries of salmeterol- fluticasone Easyhaler have commenced. Dexdor Parkinson’s drugs ● Dexdor sales continued to grow ● Sales lower than in in most countries. Sign
Slide 12: Sales of Proprietary Products at level with comparative period
Sales of Proprietary Products at level with comparative period 1−9/2018 EUR million -5% 90 5% 80 6% 80 76 +17% 70 64 +2% 29% +2% 17% 60 55 47 48 50 43 43 40 -14% 30 18 16 18% 25% 20 10 Parkinson: Stalevo, Comtess & Comtan 0 Easyhaler Parkinson’s Easyhaler Dexdor Simdax Precedex Dexdor drugs family S
Slide 13: Sales of Parkinson's drugs decreased from comparative period, as anticipated
Sales of Parkinson's drugs decreased from comparative period, as anticipated Sales of Orion's branded Parkinson's drugs by Sales, EUR million market area, MAT6/2018 60 2% 50 40 30% 36% 30 20 10 0 Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3 32% Europe 2013 2014 2015 2016 2017 2018 Japan ROW Deliveri
Slide 14: Easyhaler product family grows − Salmeterol-fluticasone deliveries have commenced
Easyhaler product family grows − Salmeterol-fluticasone deliveries have commenced Sales, EUR million 25 ● Product family total sales: +17% ● Budesonide-formoterol Easyhaler: +27% 20 ● Budesonide-formoterol Easyhaler 15 – On sale in all key European markets. – Market share of volume varies: 10 e.g. S
Slide 15: Sales of Dexdor intensive care sedative continued to grow in most European markets
Sales of Dexdor intensive care sedative continued to grow in most European markets Total value of the Sales, EUR million European sedatives 20 18 market: EUR 553 million 16 (+3%) 14 12% 12 10 12% 8 65% 6 4 2 11% 0 Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3 2013 2014 2015 2016 2017 2018 Propofol EU
Slide 16: Specialty Products
Specialty Products GRION Building well-being
Slide 17: Specialty Products
Specialty Products ● Continued price competition ● Sales of biosimilars in Finland has led to a decline continued to decrease due in the entire reference priced to the situation of tenders, prescription drug market. tightened competition and – Estimated impact on Orion declined price level. EUR 15 m
Slide 18: Specialty Products: tightened competition and lower sales of biosimilars showed as a decrease in sales
Specialty Products: tightened competition and lower sales of biosimilars showed as a decrease in sales Development of net sales Net sales by market area Net sales by product EUR 1−9/2018 1−9/2018 million -8% 250 217 14% 6% 200 200 150 13% 58% 24% 70% -29% +1% 100 72 51 47 47 15% 50 0 Finland Scandin
Slide 19: In Finland, price competition has led to a decline in the entire market of reference priced prescription 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 (1–9/2018) in Finland 368 91 MEUR (397) MEUR (102) Market development O
Slide 20: Orion is strong in home market Finland
Orion is strong in home market Finland Human pharma market in Finland (1−9/2018) Medicinal and non-medicinal products Reference Self-care in hospital and pharmacy channels: EUR 1,990 million priced products prescription Orion market share EUR million drugs in pharmacy Orion market share 230 25% 250
Slide 21: Research and development
Research and development
Slide 22: Orion and Bayer's phase III trial of darolutamide for non-metastatic castration-resistant prostate cancer
Orion and Bayer’s phase III trial of darolutamide for non- metastatic castration-resistant prostate cancer: Primary endpoint was met ● Darolutamide significantly extended metastasis- free survival compared to placebo. ● The full data will be presented at an upcoming scientific meeting. ● Bayer plans
Slide 23: 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 US
Slide 24: Other late-phase clinical trials are also making progress
Other late-phase clinical trials are also making progress ● ODM-201/darolutamide for metastatic ● ODM-109/orally administered levosimendan hormone-sensitive prostate cancer: for ALS: – Phase III trial ARASENS in collaboration – 3-year REFALS trial started in the spring, with Bayer ongoing. recruitme
Slide 25: 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 26: Patient safety is the guiding value in Orion's operations
Patient safety is the guiding value in Orion’s operations
Slide 27: We assess product safety throughout the lifecycle
We assess product safety throughout the lifecycle Interim Report 1–9/2018 © Orion Corporation 24 October 2018 27
Slide 28: In 2017 there were fewer product recalls than in the year before, number of audits increased
In 2017 there were fewer product recalls than in the year before, number of audits increased Audits by 3rd Audits Product by Orion recalls ● No critical observations in audits parties carried out by authorities, 81 13 customers and partners. 314 4 10 ● Slightly less critical observations 55 269 than
Slide 29: Outlook
Outlook
Slide 30: Outlook for 2018 remains unchanged
Outlook for 2018 remains unchanged Net sales Due to generic and price competition Orion estimates that in 2018 the net sales excluding Orion Diagnostica will be at the same level or slightly lower than in 2017 (net sales were EUR 1,034 million excluding Orion Diagnostica in 2017). Operating Orion co
Slide 31: Orion calendar
Orion calendar 2019 Financial Statements Release 2018 6/2/2019 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
Slide 32: Building well-being
Building well-being GRIoN Building well-being