Orion Investor presentation
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
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 these strategies. These statements are subject to risks and uncertainties. Actual results may differ substantially from those stated in any forward-looking statement. This is due to a number of factors, including the possibility that Orion may decide not to implement these strategies and the possibility that the anticipated benefits of implemented strategies are not achieved. Orion assumes no obligation to update or revise any information included in this presentation. Investor Presentation © Orion Corporation 2
Content 1) Orion in brief 2) R&D 3) Highlights of 1−3/2019 4) Outlook and financials 5) Businesses 6) Sustainability 7) Financial calendar Investor Presentation © Orion Corporation 3
Key messages 11 3 5 Orion develops, Growth targeted Strong position in manufactures and through new in- the Nordic markets human house developed generics market. and animal drugs. pharmaceuticals, and APIs. Products marketed in >100 countries. 6 Core therapy 22 4 4 Balanced business Strong model: Both areas in R&D: profitability, proprietary drugs oncology, CNS and respiratory stable dividends. and generics. diseases (Easyhaler family). Investor Presentation © Orion Corporation 5
Orion at a glance (2018 figures) Net sales Sales by business Sales by market area 977 MEUR Operating profit 5% 2% 15% 8% 253 MEUR 37% 32% 6% Personnel 3,154 R&D investments 48% 31% 104 MEUR 16% 6 production sites in Finland Proprietary Products Finland Scandinavia Specialty Products Other Europe Own sales unit Animal Health North America Fermion in 26 European countries Contract manufacturing ROW On 21 April 2018, Orion signed an agreement on the sale of all shares in Orion Diagnostica Oy (i.e. the Orion Diagnostica business division). Following the transaction, that was completed on 30 April 2018, Orion Diagnostica business is reported as discontinued operation. All figures in this presentation are for continuing operations, if not otherwise stated. Investor Presentation © Orion Corporation 6
Steady development despite patent expiries Net sales Operating profit EUR million EUR million 33% 1 000 11% 300 32% 9% 250 800 7% 31% 5% 200 30% 600 29% 3% 150 400 1% 28% 100 200 -1% 27% -3% 50 26% 0 -5% 0 25% 2011 2012 2013 2014 2015 2016 2017 2018 Parkinson franchise + Precedex Operating profit Other products Operating profit margin Growth, % On 21 April 2018, Orion signed an agreement on the sale of all shares in Orion Diagnostica Oy (i.e. the Orion Diagnostica business division). Following the transaction, that was completed on 30 April 2018, Orion Diagnostica business is reported as discontinued operation. All figures in this presentation are for continuing operations, if not otherwise stated. Investor Presentation © Orion Corporation 7
Orion’s product mix has changed Sales by business 2011 Sales by business 2018 Net sales, EUR million 3% 5% 2% 5% 1 200 8% 8% 1 050 47% 37% 900 750 600 450 37% 48% 300 150 0 Proprietary Products Specialty Products Animal Health Fermion Contract manufacturing & other Investor Presentation © Orion Corporation 8
Our businesses 1 Proprietary Products Specialty Products In-house developed drugs and other drugs with valid product 3 Generic prescription drugs, OTC and non-medicinal 5 protection products, biosimilars Animal Health Fermion Medicine and well-being Active pharmaceutical products for animals ingredients (APIs) 2 4 4 6 Contract Manufacturing Production for other pharmaceutical companies Investor Presentation © Orion Corporation 9
Orion’s strategy – Mission to build well-being Growth Sustainability Investor Presentation © Orion Corporation 10
Orion had ~73,000 shareholders on 31 December 2018 By number of shares By number of votes Households (Finnish 5% retail) 3% 5% 9% Non-Finnish holders and 8% nominee-registered 6% Private corporations 7% 42% 13% Public sector 62% Non-profit institutions 7% 32% Financial and insurance corporations Other Investor Presentation © Orion Corporation 11
Research and development
Focus areas of Orion’s R&D Proprietary products Animal Health Fermion • Central nervous system • Orion utilises the R&D of • APIs to Orion’s • Oncology proprietary products to proprietary products • Respiratory develop new medicines • Generic APIs (Easyhaler product for animals. • Contract development family) for pharmaceutical companies Investor Presentation © Orion Corporation 13
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 mo. Collaboration with partners Collaboration with partners Investor Presentation © Orion Corporation 14
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-203 (targeted FGFR+VEGFR inhibitor) Solid tumours I II ODM-207 (BET protein inhibitor) Cancer I ODM-208 (CYP11A1 inhibitor) Prostate cancer (CRPC) I Prostate cancer (CRPC), I ODM-209 (CYP11A1 inhibitor) breast cancer I 1) In collaboration with Bayer = Completed =Status changed More information on R&D projects: www.orion.fi/en/rd/orion-rd/pipeline/ = Ongoing Interim Report 1–3/2019 ©Orion Corporation 25 April 2019 15
ARAMIS trial: Efficacy and safety of darolutamide in non- metastatic castration- resistant prostate cancer
Orion and Bayer’s phase III trial of darolutamide for non-metastatic castration- resistant prostate cancer ● Detailed data presented at ● Bayer is also having discussions with the ASCO GU on 14 February 2019 other health authorities regarding the and simultaneously published in the submission for marketing authorisation New England Journal of Medicine. application. ● Darolutamide significantly extended ● Darolutamide has been granted Fast metastasis-free survival with a Track designation by the U.S. Food and favourable safety profile compared Drug Administration (FDA). If the to placebo. process proceeds as planned, the sales could in the best-case scenario start in ● The application for marketing the US already at the end of 2019. authorisation has been submitted in U.S., Japan and EU. ● Phase III ARASENS trial for metastatic prostate cancer continues. Investor Presentation © Orion Corporation 17
Financial impacts of darolutamide ● Bayer 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 the US • EUR 20 million in the EU • EUR 8 million in Japan ● Tiered royalties on product sales − Approx. 20%, including production revenue. ● Potential one-off payments if certain sales targets are met. Investor Presentation © Orion Corporation 18
Non-metastatic castration-resistant prostate cancer (nmCRPC) ● A form of prostate cancer associated with rising PSA (Prostate-Specific Antigen) levels despite androgen deprivation therapy (ADT). ● The cancer has not yet spread beyond the prostate region. ● High risk for progression to metastatic disease. ● Until recently, there have been no effective treatment options for this stage. The goal is to achieve disease control without impacting patients’ daily lives. Investor Presentation © Orion Corporation 19
Until recently, there have been no effective treatment options for CRPC patients who have rising Prostate-Specific Antigen (PSA) levels while on ADT and no detectable metastases Non-metastatic CRPC 20
Darolutamide has demonstrated low blood-brain barrier penetration that may lead to lower incidence of adverse events ● Darolutamide is a non-steroidal androgen receptor antagonist that binds to the receptor with high affinity and inhibits the growth of prostate cancer cells. ● In preclinical studies, darolutamide has demonstrated low blood-brain barrier penetration. ● This may explain the overall low incidence of central nervous system related adverse events. Investor Presentation © Orion Corporation 9
ARAMIS Phase III trial design 1,200 mg darolutamide + ADT Randomization 1,509 patients (600 mg twice a day) − 955 patients Men with nmCRPC currently 2:1 being treated with ADT, and at high risk for developing Placebo twice a day + ADT metastatic disease − 554 patients Primary endpoint Secondary endpoints ● Metastasis-free survival (MFS) ● Overall survival (OS) ● Time to pain progression ● Time to initiation of first cytotoxic chemotherapy ● Time to first symptomatic skeletal event ● Safety and tolerability 11
Summary of results: Darolutamide shows substantial efficacy and favourable safety profile ● Darolutamide significantly improves ● Darolutamide has a favorable metastasis-free survival (MFS): safety profile: – Median 40.4 months with darolutamide – It didn’t increase rates of critical adverse vs 18.4 months with placebo events (seizures, falls, fractures, rash, cognitive disorder, mental impairment, – Overall improvement of 22 months hypertension) compared to placebo. ● Positive trend in overall survival (OS): – Only fatigue occured in >10% of patients. – 29% reduction in risk of death at interim – Discontinuation rates similar between analysis (P=0.045). darolutamide and placebo. ● Significant benefit over placebo for time to pain progression: – 40.3 months vs. with placebo 25.4 months Investor Presentation © Orion Corporation 13
ARASENS trial continues in order to expand the indication to metastatic prostate cancer Patients Endpoints ● Men with metastatic, hormone-sensitive ● Primary: prostate cancer Darolutamide over placebo Treatment in overall survival ● Darolutamide plus ● Secondary: androgen deprivation therapy Time to castration resistance, time to and six cycles of docetaxel (chemotherapy) antineoplastic therapy, time to first symptomatic skeletal event, time to initiation of opioids, time to pain progression, and to characterize the safety and tolerability of darolutamide Status ● Recruitment finalized, estimated completion of the trial in 2022. 24 Investor Presentation © Orion Corporation
Global prostate cancer estimates (2018) 70 12nd 35th 5 most commonly leading cause of diagnosed death from cancer malignancy in men 50 60 70 80 in men worldwide 50 60 70 80 21.2 million men 358,000 died from 4 6 50+ Mainly affects men diagnosed with the disease over 50, the risk prostate cancer increases with age Investor Presentation © Orion Corporation 25
ODM-109: Oral levosimendan for ALS ● First patients recruited in July ● 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, orally administered Designation in the US and in the EU. levosimendan can help maintain breathing ● It is a molecule originally developed by Orion for capacity and benefit overall functioning the treatment of acute decompensated heart of ALS patients. failure. Simdax has been in the market for this ● Orion is investing approximately EUR 60 million indication since 2000. over three years in the trial. Investor Presentation © Orion Corporation 26
ODM-109 (ALS): REFALS phase III trial 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: Approx.100 clinical sites ALS functional rating scale (Overall • US, Canada, assessment of Europe, ALS symptoms) Australia www.clinicaltrials.gov: NCT03505021 Investor Presentation © Orion Corporation 27
ALS (Amyotrophic lateral sclerosis) as a rare disease 1−2∕ ~16,800 ~12,500 ~450−500 100,000 Patients Incidence Patients Patients in the US in 2017 in Europe in Finland Investor Presentation © Orion Corporation 28
ODM-208: Pan-steroid hormone synthesis inhibitor (CYP11A1 inhibitor) for castration-resistant prostate cancer ● Steroid hormones stimulate the growth of hormonally regulated cancers, such as most prostate and breast cancers. ● Hormonal treatments are highly effective, but Steroid producton drug resistance will often eventually emerge switched off and cancer will start growing again. ● Preclinical studies have shown that ODM-208 Steroids from inhibits the synthesis of steroids hormones. It adrenal, testes and tumor has potential efficacy also for those cancers that have become resistant to the standard ODM-208 hormonal treatments. with androgen ● The steroid hormones that are needed and do deprivation not promote cancer growth are replaced with therapy additional medication. Investor Presentation © Orion Corporation 29
Highlights in January–March 2019
Marketing authorisation applications for darolutamide submitted in main markets 1 Marketing authorisation applications for the prostate cancer drug darolutamide 3 Net sales of Proprietary Products slightly declined from the previous year. Easyhaler, submitted in the main markets Dexdor and Simdax sold well. US, Japan and Europe. Net sales of Specialty Products decreased in Finland and Eastern Europe, but increased in Scandinavia. Net sales and operating profit Orion has launched a Phase I 2 were lower than in the comparative period. R&D expenses increased. 4 clinical trial on the ODM-209 molecule. This molecule is a selective hormone synthesis inhibitor much like the ODM-208. Outlook remains unchanged. Orion will not independently pursue a trial on ODM-104 for Parkinson's disease. Investor Presentation © Orion Corporation 31
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 (REFALS). sales force in Germany. billion EUR In-licensing and Investments 4 Capital gain from 2 the sale of Orion product acquisitions: supporting growth Diagnostica, estimated E.g. reacquisition of at EUR 30 million EUR 128 million, Stalevo sales rights supports growth in 2019. in Europe. opportunities. Investor Presentation © Orion Corporation 32
Key figures 1−3/2019 Net sales Operating profit Operating profit Cash flow per share margin before financial items 241 55 23% 0.40 MEUR (247) MEUR (70) (28%) EUR (0.39) -3% -21% +3% Investor Presentation © Orion Corporation 33
Development of net sales and operating profit Net sales Operating profit 247 7 3 70 1 2 3 3 2 1 3 2 4 241 7 55 26 26 25 22 15 15 (1) Product sales without sales margin and product mix change and exchange rate effect (2) Product sales margin and product mix change but without exchange rate effect (3) Exchange rate effect on gross margin Investor Presentation © Orion Corporation 34
Geographical breakdown and development of net sales 1−3/2019 1−3/2018 1−3/2019 EUR million 11% +10% 90 -7% 6% 31% 80 70 60 +7% 50 -29% 40 34% 18% 30 -1% 20 Finland 10 Scandinavia Other Europe 0 North America Finland Scandinavia Other North Other Other markets Europe America markets Investor Presentation © Orion Corporation 35
Net sales by business division EUR million 1−3/2019 -5% 140 2% 118 6% 120 111 -4% 9% 100 89 93 37% 80 60 +3% +21% 46% 40 +8% 21 20 20 15 12 5 4 0 Proprietary Products Specialty Proprietary Animal Fermion Contract Specialty Products Products Products Health manufacturing Animal Health & other Fermion 1−3/2019 1−3/2018 Contract manufacturing & other Investor Presentation © Orion Corporation 36
Best-selling pharmaceuticals 1–3/2019 Net sales Change vs . Indication (EUR million) 1−3/2018 1. Asthma, COPD 26 +21% 2. Parkinson’s disease 21 -25% 3. Intensive care sedative 19 +10% 4. Acute heart failure 17 +16% 5. Animal sedatives 10 +15% Rheumatoid arthritis, inflammatory 6. Biosimilars bowel diseases, lymphoma 9 -12% 7. Inflammatory pain 6 +5% 8. Divina series Menopausal symptoms 5 +8% 9. Anticoagulant 3 -24% 10. Generic entacapone products Parkinson’s disease 3 -29% = Products of Proprietary Products business division Investor Presentation © Orion Corporation 37
Proprietary Products
Easyhaler became the top proprietary product EUR million 1−3/2019 +21% -25% 30 28 26 3% 3% +10% 25 22 21 19% +16% 24% 20 19 18 17 15 14 10 -52% 22% 5 29% 5 3 Parkinson's: Stalevo, Comtess & Comtan 0 Easyhaler Easyhaler Parkinson's Dexdor Simdax Precedex Dexdor family drugs Simdax Precedex 1−3/2019 1−3/2018 Others Investor Presentation © Orion Corporation 39
Easyhaler product family will be a key source of growth in the next few years ● Budesonide-formoterol Easyhaler Sales, EUR million continued strong growth. 30 ● Product family total sales: +21% 25 ● Budesonide-formoterol Easyhaler: +35% 20 – Strong market position in some countries, 15 such as Sweden (market share was 34%* in February). 10 – Growth still attainable in certain markets. Investments in sales and marketing made 5 particularly in Germany (market share was 0 7%* in February). Q1Q2Q2Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4 Q1 ● Salmeterol-fluticasone sales started in the 2019 first European countries in late 2018. 2014 2015 2016 2017 2018 Budesonide-formoterol Easyhaler Others ● Development of seventh product, tiotropium, continues. *) Market shares of sales in EUR. Investor Presentation © Orion Corporation 40
Orion is taking over the sale of its proprietary Parkinson’s drugs in Europe Breakdown of sales of Orion's branded Parkinson's drugs by market area 50 Sales, EUR million 45 40 2% 35 30 25 31% 20 34% 15 10 5 0 Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4 Q1 2014 2015 2016 2017 2018 2019 Europe 33% Japan Deliveries of Parkinson's drugs (Stalevo, ROW Comtess/Comtan) to key partners USA Orion's own sales Source: IQVIA, MAT12/2018 Investor Presentation © Orion Corporation 41
Sales of Dexdor intensive care sedative continued to grow – patent expired at the end of March Total value of European sedatives market: EUR 569 million (+3%) Sales, EUR million 20 18 12% 16 14 12% 12 65% 10 8 11% 6 4 2 0 Propofol EUR 368 million (+4%) Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Midazolam EUR 62 million (-3%) Dexmedetomidine EUR 70 million (+8%) 2014 2015 2016 2017 2018 2019 Remifentanil EUR 69 million (+4%) Source: IQVIA, MAT 12/2018 Investor Presentation © Orion Corporation 42
Specialty Products
Specialty Products: price competition continued especially in Finland Development of net sales Net sales by region Net sales by product EUR 1−3/2019 1−3/2019 million -4% 80 68 10% 8% 70 65 60 12% 50 58% 26% 66% 40 +6% -8% 30 22 21 20 14 15 20% 10 0 Finland Scandinavia Eastern Finland Generic drugs Europe and Scandinavia Self-care products Russia 1−3/2019 1−3/2018 Eastern Europe and Russia Biosimilars Other markets Investor Presentation © Orion Corporation 44
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 (1–3/2019) in Finland MEUR 106 (118) MEUR 28 (30) Market development Orion's development -10% -7% Source: Pharmarket sales statistics 1–3/2019 Investor Presentation © Orion Corporation 45
Orion is strong in home market Finland Human pharma market in Finland 1−3/2019 Self-care Medicinal and non-medicinal products Reference priced products in hospital and pharmacy channels: EUR 676 million prescription Orion market share in EUR million drugs pharmacy 80 76 Orion 70 60 24 market share in pharmacy 24% 26% 45 (24%) 50 40 30 26 Human 25 25 26 (26%) pharmaceuticals 30 20 total Orion market share 10 in hospital & 0 pharmacy 11% Ratiopharm Sanofi Bayer Roche MSD Orion Self-care products (pharmacy channel) Reference priced prescription drugs (pharmacy channel) (12%) Source: Pharmarket sales statistics 1–3/2019 Investor Presentation © Orion Corporation 46
Orion's key business targets in 2019 1. Preparation for the • Marketing authorisation applications commercialisation of submitted in main markets. darolutamide. ARASENS trial (metastatic prostate cancer) • With recruitment completed, the continues in order to expand the ARASENS trial continues as planned. indication for the molecule. 2. Development of • Patient recruitment is proceeding as orally administered planned levosimendan (ODM-109) (REFALS) for ALS in phase III clinical trial and preparation for its possible commercialisation. 3. Strengthening Orion’s • Orion’s sales volume in Finland grew position as the most faster than the market. significant provider of generic drugs in Finland. Competitive pricing. 47
Orion's key business targets in 2019 4. Competitive product portfolio in • Orion's sales volume in Finland grew Specialty Products and faster than the market. strengthening of product launches. 5. Accelerating the growth of the • Easyhaler product family sales Easyhaler product family and increased by 21 per cent. strengthening its market position. Salmeterol-fluticasone launch in Europe. 6. Evaluation of new • The work continues. in-licensing opportunities in Europe, particularly in the area of hospital care. 48
Outlook
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 and marketing and the market and gradually estimated EUR 30 million. research. expanding generic competition for Orion’s old proprietary drugs. Investor Presentation © Orion Corporation 50
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 Operating profit is estimated to be at the same level as in 2018 (operating profit in 2018 was EUR 253 million). The estimated operating profit includes the possible EUR 45 million milestone payment associated with the commercialisation of darolutamide as well as significant investments in actions to generate growth. Investor Presentation © Orion Corporation 51
Financials
Orion’s financial objectives Growing net sales more rapidly than ≥ growth of the pharmaceuticals market. Achievement of this objective requires continuous investment in Keeping the equity ratio at least 50%. development of the product portfolio. Distributing an annual dividend that > Maintaining profitability at a good level. The aim is operating profit that exceeds 25% of net sales. € in the next few years will be at least EUR 1.30 per share, and increasing the dividend in the long term. Investor Presentation © Orion Corporation 53
Financial objectives Net sales Operating profit Dividend 1 200 8% 30% 1,60 300 27% 6% 275 1,55 1 000 250 24% 1,50 4% 225 21% 800 200 1,45 2% 18% 175 1,40 600 150 15% 0% 125 12% 1,35 400 100 9% 1,30 -2% 75 6% 1,25 200 -4% 50 25 3% 1,20 0 -6% 0 0% 1,15 2016* 2018** 2012 2013 2014 2015 2017 2015 2016 2012 2013 2014 2017 2018 2015 2012 2013 2014 2016 2017 2018 Net sales, EUR Operating profit, EUR million Dividend per share, EUR million Operating profit margin Target Target *) 2016: includes extra dividend EUR 0.20 **) 2018: Board proposal On 21 April 2018, Orion signed an agreement on the sale of all shares in Orion Diagnostica Oy (i.e. the Orion Diagnostica business division). Following the transaction, that was completed on 30 April 2018, Orion Diagnostica business is reported as discontinued operation. All figures in this presentation are for continuing operations, if not otherwise stated. Investor Presentation © Orion Corporation 54
Key figures by quarter Net Netsales, sales,EUR EURmillion million Operating Operating profit, profit, EUREUR million million 1 500 400 Q4 Q4 1 000 300 59 Q3 273 255 262 280 266 262 Q3 66 55 51 71 200 92 69 237 238 239 259 242 222 67 64 59 55 45 Q2 500 Q2 84 71 248 277 255 273 261 246 100 61 86 74 70 Q1 249 245 260 262 266 247 Q1 74 67 83 80 88 70 0 0 13 14 15 16 17 18 13 14 15 16 17 18 Cash Cashflow flowper pershare share Basic Basic earnings earnings per share, per share, EUR EUR before Before financial items,EUR financial items*, EUR 2,00 2,50 Q4 0,22 Q4 1,50 0,34 2,00 0,36 0,40 0,29 0,28 0.38 Q3 0,52 0,38 1,50 0,38 0,39 Q3 1,00 0,35 0,32 0,31 0,40 0,35 0,24 Q2 1,00 0,41 0,22 0,41 0,47 0,39 0,44 0,67 Q2 0,33 0,48 0,40 0,46 0,47 0,50 Q1 0,50 0,62 0,29 0,07 1,36 0,29 0,27 Q1 0,39 0,37 0,47 0,45 0,48 0,38 0,19 0,30 0,38 0,29 0,33 0,39 0,00 0,00 0,07 13 14 15 16 17 18 13 14 15 16 17 18 *) continued and discontinued operations On 21 April 2018, Orion signed an agreement on the sale of all shares in Orion Diagnostica Oy (i.e. the Orion Diagnostica business division). Following the transaction, that was completed on 30 April 2018, Orion Diagnostica business is reported as discontinued operation. All figures in this presentation are for continuing operations, if not otherwise stated. Investor Presentation © Orion Corporation 55
Key figures Change Orion’s key figures 2013 2014 2015 2016 2017 2018 vs. 2017 Net sales, EUR million 1,006.9 1,015.3 1,015.6 1,073.5 1,033.6 977.5 -5.4% Operating profit, EUR million 267.7 272.4 266.6 314.6 284.1 252.8 -11.0% Profit before taxes, EUR million 264.0 267.8 262.3 310.9 277.7 248.4 -10.6% R&D expenses, EUR million 101.9 106.2 108.1 118.2 99.1 104.0 +4.9% Equity ratio, % 53.6% 52.3% 57.4% 60.8% 64.6% 68.8% Gearing, % 8.4% -4.7% -9.6% -12.4% -1.9% -17.1% ROCE (before taxes), % 38.5% 36.6% 35.7% 40.9% 36.2% 44.3% Return on equity, % 40.3% 41.1% 37.5% 40.3% 34.2% 45.5% Basic earnings per share, EUR 1.46 1.50 1.48 1.77 1.56 1.40 -10.3% Cash flow per share before financial items, EUR 1.02 1.72 1.51 1.62 1.09 2.32 +112.4% Dividend per share, EUR 1.25 1.30 1.30 1.55* 1.45 1.50 +3.4% *) 2016: dividend includes extra dividend of EUR 0.20 The figures in the table include both continuing and discontinued operations. Investor Presentation © Orion Corporation 56
Income statement Change vs. Formation of profits, EUR million 2013 2014 2015 2016 ADJ.2017 2018 2017 Net sales 1,006.9 1,015.3 1,015.6 1,073.5 1,033.6 977.5 -5.4% Cost of goods sold -393.5 -401.7 -405.8 -421.7 -417.6 -387.9 -7.1% Gross profit 613.4 613.6 609.8 651.8 616.0 589.6 -4.3% Other operating income and expenses 5.6 1.7 1.5 24.3 4.9 5.5 +10.8% Sales and marketing expenses -204.9 -193.4 -190.4 -194.7 -188.9 -195.3 +3.4% R&D expenses -101.9 -106.2 -108.1 -118.2 -99.1 104.0 +4.9% Administrative expenses -44.5 -43.3 -46.2 -48.7 -48.8 -43.0 -11.8% Operating profit 267.7 272.4 266.6 314.6 284.1 252.8 -11.0% Profit before taxes 264.0 267.8 262.3 310.9 277.7 248.4 -10.6% Profit for the period for continuing operations 219.1 197.3 -9.9% Profit for the period for discontinued operations 7.0 132.9 Profit for the period 206.2 211.3 208.2 249.0 226.0 330.3 +46.2% The figures in the table include both continuing and discontinued operations. Investor Presentation © Orion Corporation 57
Financial position Change Change EUR million 12/18 12/17 % EUR million 12/18 12/17 % Non-current assets total 418.5 434.7 -3.7% Inventories 222.1 225.4 -1.5% Equity total 773.1 679.7 +13.7% Interest-bearing non-current Trade receivables 188.8 199.0 -5.1% liabilities 0.6 150.3 -99.6% Other receivables 33.7 32.4 +4.0% Non-current liabilities total 59.8 196.2 -69.5% Cash & cash equivalents & money market investments 283.7 164.1 +72.9% Current liabilities total 313.8 179.7 +74.7% Current assets total 728.2 620.8 +17.3% Liabilities total 373.6 375.8 -0.6% Assets total 1,146.7 1,055.5 +8.6% Equity and liabilities total 1,146.7 1,055.5 +8.6% The consolidated statement of financial position includes both continuing and discontinued operations. Investor Presentation © Orion Corporation 58
Development of capital expenditure Orion Capex, EUR million 90 80 70 60 50 Property, plant and equipment 40 30 Intangible assets 20 Depreciation, amortisation and 10 impairment 0 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 Investor Presentation © Orion Corporation 59
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 2012 2013 2014 2015 2016 2017 2018 2012 2013 2014 2015 2016 2017 2018 Receivables Receivables Inventories Inventories Short-term non-interest bearing liabilities Short-term non-interest bearing liabilities Net Working Capital Net Working Capital Investor Presentation © Orion Corporation 60
Dividend distribution policy • 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 1,75 100% 1,50 0,06 0,12 95% 1,25 90% 0.10 85% Repayment of capital per share 1,00 80% 1,50 0,75 Dividend per share 75% 0,50 70% Dividend payout ratio 1.30 1,00 0,95 1,00 1,20 1,30 1,30 1,25 1,30 1,55 1,45 0,25 65% 0,00 60% 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2016: includes extra dividend EUR 0.20 2018: Board proposal Investor Presentation © Orion Corporation 61
Orion B share performance January 2016 – December 2018 Index 31/12/2015=100 200 Orion B 94.71 190 Orion B total return 104.10 180 Europe/Pharmaceutical 86.94 170 OMXH-Portfolio 107.2 160 150 140 130 120 110 100 90 80 70 60 31.12.15 29.2.16 30.4.16 30.6.16 31.8.16 31.10.16 31.12.16 28.2.17 30.4.17 30.6.17 31.8.17 31.10.17 31.12.17 28.2.18 30.4.18 30.6.18 31.8.18 31.10.18 31.12.18 Investor Presentation © Orion Corporation 62
Business units
Proprietary Products: In-house developed prescription drugs with valid product protection Net sales EUR million 400 Global sales and Other 350 R&D partner Simdax networks 300 250 Easyhaler 200 150 Dexdor 100 Precedex Key drivers: 50 0 Stalevo/Comtess Easyhaler, Simdax Generic competition 2012 2013 2014 2015 2016 2017 2018 /Comtan Possible milestones New products from R&D pipeline Investor Presentation © Orion Corporation 64
Proprietary human pharmaceuticals developed by Orion Product Indication Year Year Indication Sedative for ICU use 2011 Salmeterol- 2018 fluticasone Easyhaler® Parkinson’s disease 2003 Budesonide- Acute decompensated 2014 2000 formoterol Easyhaler® heart failure Formoterol Easyhaler® 2004 Asthma and COPD Sedative for ICU use 1999 Budesonid Easyhaler® 2002 Parkinson’s disease 1998 Beclomet Easyhaler® 1994 Breast cancer 1988 Buventol Easyhaler® 1993 Investor Presentation © Orion Corporation 65
Diverse treatment options for asthma and COPD by utilizing the same inhaler technology ● Easyhaler is a dry-powder inhaler developed in-house ● Orion has developed Easyhaler-adapted dry powder formulations of several well-known generic active substances: – salbutamol, beclometasone, budesonide, formoterol, salmeterol and fluticasone ● Key benefits: – Dosing accuracy and consistent deposition – Easy to teach, learn and use – A wide range of products Investor Presentation © Orion Corporation 66
Easyhaler product family is expanding 2018 Tiotropium development started Investor Presentation © Orion Corporation 67
Specialty Products: Generic prescription drugs, biosimilars and OTC including also non-medicinal products EUR million 550 22% 500 20% Portfolio of 18% 450 16% hundreds 14% 400 12% of products 350 10% 300 8% 6% 250 4% 200 2% 0% 150 -2% 100 -4% 50 -6% -8% 0 -10% Net sales Growth, % Investor Presentation © Orion Corporation 68
Animal Health EUR million 105 12% In-licensed products 90 10% sold in own sales 75 8% areas 6% 60 4% 45 2% 30 0% 15 -2% 0 -4% In-house developed Medicinal and non- 2012 2013 2014 2015 2016 2017 2018 proprietary products medicinal products for Net sales Growth, % sold globally through companion animals own sales network and livestock and through partners Investor Presentation © Orion Corporation 69
Fermion has an important strategic role EUR million 70 50% 60 40% Active 50 30% pharmaceutical 40 20% ingredients (APIs) for Orion’s own 30 10% Proprietary Products 20 0% 10 -10% 0 -20% 2010 2011 2012 2013 2014 2015 2016 2017 2018 Generic APIs for Contract Orion and other development and Net sales* Growth, % pharma companies manufacturing of APIs *) Excluding supply to Orion Investor Presentation © Orion Corporation 70
Fermion's new production plant operational in Hanko – nearly 100% of production is exported ● Special expertise in demanding production of active pharmaceutical ingredients (APIs), e.g. extremely potent substances. ● The aim is to captively manufacture the APIs for Orion's in-house developed proprietary drugs, such as darolutamide. ● Modernised, advanced technology at Hanko EUR >30 6,000 200-> ~20 strengthens Fermion's global competitive position, meets increasingly strict regulatory million m2 300 t requirements and provides the means to meet growing demand. Expansion Production facility Enables Number of APIs investment and equipment capacity manufactured ● The Hanko facility manufactures 2016−2018 for the production increase at Hanko azathioprine and entacapone, among of APIs others, in which Fermion is the leading manufacturer globally. Investor Presentation © Orion Corporation 71
Contract manufacturing & other EUR million 50% 40 35% Pharmaceutical 20% manufacturing for 30 5% other companies -10% 20 -25% 10 -40% -55% 0 -70% 2012 2013 2014 2015 2016 2017 2018 Net sales Growth, % Investor Presentation © Orion Corporation 72
Sustainability is built into Orion’s mission
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 complaints by Orion savings target set for 2025 (Pharmaceuticals) achieved 56 238 1,074 40% 5.5 Ppm (64) (314) MWh (3,725) (31%) LTIF 1 (6.3) Investor Presentation © Orion Corporation 74
We assess product safety throughout the lifecycle Investor Presentation © Orion Corporation 75
Orion calendar Capital Markets Day Helsinki, 22 May 2019 Half-Year Financial Report 17/7/2019 Interim Report 1−9/2019 23/10/2019
Investor Relations Jari Karlson CFO jari.karlson@orion.fi +358 10 426 2883 Heidi Ahti Executive Assistant (Investor meeting requests) heidi.ahti@orion.fi +358 10 426 2169 www.orion.fi/EN/Investors twitter.com/OrionCorpIR
Building well-being
You can also read