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1 Tuesday, December 16th 2014 – M2 AREIPS Lille 2 » COMPANY HISTORY » ID ˃ ˃ ˃ ˃ ˃ ˃ Key Figures Worldwide presence Organization chart STADA’s activities EG Labo Employees » FINANCIAL ANALYSIS » STADA’S STRATEGY » OUTLOOKS » SWOT 2 3 4 » COMPANY HISTORY » ID ˃ ˃ ˃ ˃ ˃ ˃ Key Figures Worldwide presence Organization chart STADA’s activities EG Labo Employees » FINANCIAL ANALYSIS » STADA’S STRATEGY » OUTLOOKS » SWOT 5 » € 2,01 Billion » 29 countries ˃ 24 European countries ˃ 5 Asian countries » Represented by 47 subsidiaries » ⅔ of sales are generics » 5th worldwide leader in generics 6 https://www.stada.com/company/about-stada/overview.html ≈ +10% 2500 2014 2000 2082 1838 1627 1715 M€ 1500 1000 500 0 2010 2011 2012 Years http://www.zonebourse.com/STADA-ARZNEIMITTEL-AG 2013 2014 e 7 3% 2% Branded Products 35% Generics Commercial Business 61% Group holdings/Other 8 https://www.stada.com/company/about-stada/overview.html • In 2009 Teva Sandoz Mylan 18% Watson Ratiopharm 10% 50% Stada 6% 6% 2% 2% BCC Research 3% Actavis Ranabxy Autres 3% 6th 9 • In 2013 10 » COMPANY HISTORY » ID ˃ ˃ ˃ ˃ ˃ ˃ Key Figures Worldwide presence Organization chart STADA’s activities EG Labo Employees » FINANCIAL ANALYSIS » STADA’S STRATEGY » OUTLOOKS » SWOT 11 Parent company 12 Parent company 13 14 » COMPANY HISTORY » ID ˃ ˃ ˃ ˃ ˃ ˃ Key Figures Worldwide presence Organization chart STADA’s activities EG Labo Employees » FINANCIAL ANALYSIS » STADA’S STRATEGY » OUTLOOKS » SWOT 15 SUPERVISORY BOARD - 9 members • 6 represented shareholders • 3 represented employees - Chairman Dr Martin ABEND - Deputy chairman Manfred KRUEGER EXECUTIVE BOARD Hartmut RETZLAFF Chairman of the EB since 1994 EB member since 1993 Helmut KRAFT Chief Financial Officer (EB member since 2010) ADVISORY BOARD - Chairman : Dr Thomas MEYER - Deputy chairman: Dr Franck-R. LEU - 9 other members Dr Matthias WIEDENFELS Chief Business Development & Central Services Officer EB member since 2013 16 » COMPANY HISTORY » ID ˃ ˃ ˃ ˃ ˃ ˃ Key Figures Worldwide presence Organization chart STADA’s activities EG Labo Employees + Generics + Branded Products + Biosimilars » FINANCIAL ANALYSIS » STADA’S STRATEGY » OUTLOOKS » SWOT 17 » Two Core segments ˃ Generics : 61 % = 1127 M€ of GS in 2013 ˃ Branded products : 35 % = 647 M€ of GS in 2013 » Generic company ˃ Pharmaceutical company that manufactures and markets generics. ˃ Focus on products with off-patent active pharmaceutical ingredients on the pharmaceutical market. » STADA: Major therapeutic areas for generics: ˃ ˃ ˃ ˃ Cardiovascular diseases Gastro intestinal diseases Inflammatory diseases …. www.stada.com 18 21,70% 35,10% Cardiovascular Dermatology 0,20% Genito-urinary/Hormonal Drugs Respiratory Rheumatology 4,30% Diabetes Oncology 4,50% 6,40% 3,40% Gastro-intestinal/HIV/Immunology 8,30% 19 http://fr.slideshare.net/AiswariyaChidambaram/pharma-tech-2013-aiswariya-chidambaram-fs Active ingredient Indication group Phospholipide referred hepatobiliary and laxative osmotic Omeprazole IPP Diclofenac AINS 20 2012: 2013: 7,3 % = 82 M€ 6,9 % = 78 M€ Omeprazole Diclofenac Sales 2012 Sales 2013 Phospholipide 0 www.stada.com 5 10 15 20 25 30 35 In M€ 21 » COMPANY HISTORY » ID ˃ ˃ ˃ ˃ ˃ ˃ Key Figures Worldwide presence Organization chart STADA’s activities EG Labo Employees + Generics + Branded Products + Biosimilars » FINANCIAL ANALYSIS » STADA’S STRATEGY » OUTLOOKS » SWOT 22 Active ingredient Apo-Go (RX) Indication group Antiparkinson (DCI:Apomorphine hydrochloride) Grippostad (OTC) Cold medecine (DCI: Paracetamol+Vit C+Cafein) Chondroxid (OTC) (DCI: Chondroïtine sulfate) For the treatment of degenerative joint diseases 23 2012: 2013: 15,7 % = 101.7 M€ 16,4 % = 105.6 M€ Chondroxid Grippostad Sales 2012 Sales 2013 Apo-Go 0 www.stada.com 5 10 15 20 25 30 35 40 45 50 In M€ 24 APO - go® » PA : Apomorphine hydrochloride » Parkinson’s disease • Short-acting (~1hr) • To help prevent or reverse "off" periods • Patients with gaps in control from their oral medications The "off" period may consist of : 25 APO - go ® » PA : Apomorphine hydrochloride » Parkinson’s disease • Used for almost 20 years • 2nd-line dopamine agonist in Parkinson's • 14-16 hours a day • Small and discreet 26 Thornton & Ross ˃ ˃ ˃ ˃ ˃ In Aug. 2013 Net purchase price approx. 226 M€ 5th OTC pharmacy business in the UK Indication: cold, pain, dermatology Employs approximately 425 people Aqualor® ˃ In Feb. 2014 ˃ Purchase price:131 M € ˃ 10 (OTC) BP presentations based on seawater (sprays and drops) ˃ In 2012 net sales generated Aqualor® products in Russia: 28 M€. ˃ Sales contribution in march 2014: 3.9 M€ 27 www.stada.com » COMPANY HISTORY » ID ˃ ˃ ˃ ˃ ˃ ˃ Key Figures Worldwide presence Organization chart STADA’s activities EG Labo Employees + Generics + Branded Products + Biosimilars » FINANCIAL ANALYSIS » STADA’S STRATEGY » OUTLOOKS » SWOT 28 Grastofil® Filgrastim Epo-zeta 2008 2011 Rituximab Trastuzumab 2013 2014 Teriparatide 29 » In 2001: BIOGENERICS Arzneimittel AG (founded by STADA) mandated DSM Biologics (subsidiary of the Dutch DSM Group, having facilities in Montreal, Canada and Groningen, The Netherlands) to develop four biosimilars: ˃ ˃ ˃ ˃ Erythropoetin (Epo), Filgrastim, Interferon a2b Interferon b1a Global Volume Market in EU: 1 billion € (2001) 30 www.stada.com » Epo-zeta: developed and manufactured by DSM Biologics » BIOCEUTICALS (subsidiary of STADA since 2000) ˃ Pursued Epo-zeta project ˃ The worldwide exclusive distribution rights for Epo-zeta » In 2006: ˃ Hospira, Inc (US) via license agreements granted by BIOCEUTICALS Marketed Epo-zeta in EU (except Germany), USA and Canada / Retacrit ® » In 2008: ˃ STADA via a sales license granted by BIOCEUTICALS Marketed Epo-zeta in Germany / Silapo® » Indications: ˃ Treatment of symptomatic anemia with chronic renal failure ˃ Treatment of anemia in adult patient receiving chemotherapy www.stada.com 31 » In 2011: STADA via non exclusive distribution rights licence granted by Gedeon Richter Plc. Hungary / Marketing of Rituximab and Trastuzumab in Europe and the CIS area. ˃ Rituximab (Mobtera®): monoclonal antibody for the treatment of various forms of cancer, European market volume ~ 1,15 B€ (in 2011) ˃ Trastuzumab (Herceptin®): monoclonal antibody for treatment of certain forms of breast cancer and stomach cancer, European market volume ~ 1,39 B€ (in 2011) » Approval is expected for the middle of 2018. 32 www.stada.com » In 2013: ˃ STADA via a sales licence granted by Apotex Inc. (the largest Canadian owned pharmaceutical company) / Grastofil® Filgrastim ˃ STADA shall assume sales of the biosimilar for nearly all EU countries. ˃ Sales are planned to commence in 2014. » Indication: ˃ Reduce the incidence of febrile neutropenia in patients with nonmyeloid malignancies + + Receiving myelo-suppressive anticancer drugs Undergoing myelo-ablative chemotherapy followed by bone marrow transplantation. 33 www.stada.com » In 2014: ˃ STADA obtained marketing rights via Richter-Helm BioTec GmbH, Hamburg for teriparatide. ˃ Teriparatide: expected to be launched on the market in 2019 under the STADA label. ˃ Throughout Europe following the expiration of the patent of the original product Forsteo®. » Indication: ˃ Treatment of: + Postmenopausal osteoporosis + Male osteoporosis + Glucocorticoid-induced osteoporosis www.stada.com 34 » COMPANY HISTORY » ID ˃ ˃ ˃ ˃ ˃ ˃ Key Figures Worldwide presence Organization chart STADA’s activities EG Labo Employees » FINANCIAL ANALYSIS » STADA’S STRATEGY » OUTLOOKS » SWOT 35 Parent company 36 » 1979: creation Laboratoires Eurogenerics Belgique » 1991: Purchased Eurogenerics by STADA AG » 1996: Foundation EG Labo–Laboratoires Eurogenerics (France) » 1999: Development accentued by a law for Social Security « right of substitution for pharmacists » » 2012: Acquisition of LERO laboratory (expert in OTC health nutrition product) » 2013: Launch nicotin gum Smoking cessation 37 7th 2010 2011 38 » 600 generics » € 31 Million of 'Unités Communes de Dispensation‘ » +4000 pharmacies » 3 millions of boxes per year » Covers 90% of substitution products 39 http://www.eglabo.fr/wp/en-chiffres/ + 16,75% 140 120.522 120 100 98.927 102.299 103.233 2010 2011 Sales (M€) 80 60 40 20 0 2009 Years http://www.societe.com/societe/e-g-labo-laboratoires-eurogenerics.html 2012 40 Parent company 41 » COMPANY HISTORY » ID ˃ ˃ ˃ ˃ ˃ ˃ Key Figures Worldwide presence Organization chart STADA’s activities EG Labo Employees » FINANCIAL ANALYSIS » STADA’S STRATEGY » OUTLOOKS » SWOT 42 • Total number: 10, 084 (on June 30, 2014) • Evolution of total number : + 19% (versus 8463, 6 months 2013) 12000 10000 8000 Employees’ number 6000 4000 2000 43 0 2009 2010 2011 2012 2013 2014 (June 30) » Distribution by functional area (on December 31,2013) Marketing/Sales Logistics 30% Finance/IT 39% Administration 4% 3% 7% 6% 11% Product development Procurement/Supply Chain Production/Quality Management 44 » Distribution by geographical area (on December 31,2013) Employees’ number 6000 5000 4000 54,1% 3000 2000 1000 14,2% 18,6% 13,1% 45 0 Germany Central Europe CIS/Eastern Europe Asia&Pacific » Distribution by functional and geographical area (on December 31,2013) 6000 Administration 5000 Product development 4000 Procurement/Supply Chain 3000 Production/Quality Management Finance/IT 2000 Logistics 1000 Marketing/Sales 0 Germany Central Europe CIS/Eastern Europe Asia&Pacific 46 » 2014: Increase of the employees’ number • By external growth – 2 Vietnamese companies » Pymepharco (1108 employees) » STADA Vietnam (505 employees) – the British supplier Thornton&Ross (147 employees) • Quite no internal growth – implementation of « STADA – build the future » since 2011 Restructuring measures 47 » High share of women in management positions: 51% (2013) » Decentralized organization of personnel management ˃ Recruitment, training, remuneration » Continual personnel development for sustainable development ˃ Career training programs (pharmaceutical, administrative and warehouse logistics areas) ˃ Foreign language classes… ˃ Internships for young individuals ˃ Talent management (program « STARS »: Searching Talent in All Regions of STADA) 48 » COMPANY HISTORY » ID ˃ ˃ ˃ ˃ ˃ ˃ Key Figures Worldwide presence Organization chart STADA’s activities EG Labo Employees » FINANCIAL ANALYSIS » STADA’S STRATEGY » OUTLOOKS » SWOT 49 50 €M 2,500 2,000 1,500 2012 2013 1,000 500 51 0 Sales Net income EBIT €M 1,400 1,200 1,000 equity 800 Non current borrowed capital 600 400 200 0 2012 2013 • Financial Independence Ratio = 0,74 < 1 52 BFR + 118 €M FRNG + 211 €M BFR + 182 €M FRNG + 308 €M T+ 126 €M T+ 92 €M 2012 2013 53 Company's ability to generate earnings from its investments : » Return on assets : ROTA = 11,2% » Return on equity : ROE = 12,2% ˃ how effectively a company's management uses investors' money ˃ STADA generated a 12,2% profit on every euro invested by shareholders ROE and ROTA are weak. 54 MC: 44 B€ MC: 16.6 B€ MC: 1.57 B€ MC: 4.9 B€ MC: Market capitalization 55 www.finance.net » COMPANY HISTORY » ID ˃ ˃ ˃ ˃ ˃ ˃ Key Figures Worldwide presence Organization chart STADA’s activities EG Labo Employees » FINANCIAL ANALYSIS » STADA’S STRATEGY » OUTLOOKS » SWOT 56 Based on 3 growth fields Acquisition area of branded products Expansion of international business activities Biosimilars 57 WHY? • Fewer regulatory interventions • More attractive margins • Contribute 58% to adjusted operating earning 58 Branded products contribute 58% to adjusted operating profit 59 STADA_Q3-2014_E HOW? In 2013: N°5 British OTC In 2014: Russian product range: Aqualor® 60 IN THE FUTURE Currently 600 M€ for Branded Product In the future 1 B€ for Branded Product Acquisition Flexitol® from LaCorium 61 https://www.stada.com/media-public-relations/press-releases/ Based on 3 growth fields Acquisition area of branded products Expansion of international business activities Biosimilars 62 WHY? • Introduction of STADA on other market • Emerging market with less competition • Benefit from the best of the country • Implant of manufacturing site 63 HOW? » Take the emerging markets at an early stage » Market in Asia & Pacific : 59% sales ˃ Initial consolidation as a subsidiary of STADA Pharmaceuticals (Beijing) Ltd. in China. ˃ Consolidation of STADA Vietnam J.V. Co., Ltd. as a subsidiary. 64 Based on 3 growth fields Acquisition area of branded products Expansion of international business activities Biosimilars 65 WHY? • Biopharmaceuticals patent-free • Lowest risk • Lowest costs 66 HOW? Opt for an in-licensing strategy based on the company’s experience with marketing in Europe and worldwide (Epo zeta) Teriparatide Filgrastim 2014 2018 Rituximab Trastuzumab 2019 67 » COMPANY HISTORY » ID ˃ ˃ ˃ ˃ ˃ ˃ Key Figures Worldwide presence Organization chart STADA’s activities EG Labo Employees » FINANCIAL ANALYSIS » STADA’S STRATEGY » OUTLOOKS » SWOT 68 » Expansion strategy ˃ For generic core segment ˃ For branded product core segment » Expansion of specific projects 69 » Pursuing the expansion strategy Global pharmaceutical growth expected: 5 to 7% per year until 2018. STADA Group: end 2013: > 1100 approval procedures > 150 API > 50 countries 724 individual products launched in 2013 7% of sales : products launched in the two last years > 16 000 products packaging marketed by the group 70 Well-filled pipeline until 2022 for some products » For Generic core segment (1) GEOGRAPHIC DISTRIBUTION OF MEDICINE SPENDING 71 IMS Market Prognosis, September 2014 IMS Institute for Healthcare Informatics, October 2014 » For Generic core segment (2) ˃ In EU: + Germany, Italy, France, UK, Spain: >€ 1,1 billion expected for sales (2014 – 2017) + Reduced costs in individual national health care systems STADA Group regional development in 2013 for generics 72 (According to STADA Report July 2014) » For Generic core segment (3) ˃ In Asia and Pacific – Market growth expected from 2013 to 2018: 14% – Licensing of STADA products in Myanmar ˃ For selected markets : 8,7% growth expected until 2018 (IMS) – Central Europe, CIS and Eastern Europe » In Russia: 10,6% growth expected (2014-2018) Development of the Russian pharmaceutical market (in € million) ₊ ₊ ₊ 2 local suppliers Niche markets Limited government regulation 73 STADA, Broker Research » For Generic core segment (5) ˃ Ongoing patent expiration 74 IMS MIDAS, June 2014 » For branded products STADA Group regional development in 2013 for Branded products ˃ Focus on individual markets ˃ Product and country-specific growth (According to STADA Report July 2014) – Focus on highly profitable branded products: » Thornton & Ross (OTC products) / Britannia (Apo-Go) » Vitaprost®, Chondroxide®, Aqualor® 75 ˃ Expansion of Vrsac site (Serbia): development center ˃ Development contracts in India (currently: 4 projects) » Expansion of specific projects ˃ OTC expansion (9th world rank, 2013) + Value-adding acquisitions + High marging portfolio products ˃ Biosimilar: new developments expected + In-licensing of Adalimumab (Humira®) from mAbxience (patentfree in US 2016, EU 2018) + Launching of Teriparatide, Rituximab, Trastuzumab biosimilars Biosimilar portfolio with low risk licensing approach 76 » COMPANY HISTORY » ID ˃ ˃ ˃ ˃ ˃ ˃ Key Figures Worldwide presence Organization chart STADA’s activities EG Labo Employees » FINANCIAL ANALYSIS » STADA’S STRATEGY » OUTLOOKS » SWOT 77 » Adapted to long-term growth potential markets ˃ Continuous flow of new products in Generics ˃ Potential launching dates scheduled > 2020. » Organic growth expected for branded products » Cost-effective production: 'time and cheap to market' strategy ˃ Launchings at the earliest point in time ˃ Best possible costs of production 78 » No own research for new API + < 3% turnover, 2013 + API without any commercial property rights + expansion of the existing product portfolio » Regulatory preparation + At least 3 years before launching date + Choice of supranational approval processes (such as in EU) 79 Generating economy through optimized batch sizes » In-house production + Low cost locations : Serbia, Russia, Bosnia-Herzegovia, Vietnam + Row material : – International networks of suppliers – Mainly low-priced suppliers in Asian countries + Own production of leading, high marging branded products + Increased proportion of in-house developments e.g from Serbia. 80 » Optimization of products already launched ˃ Development of new forms of products ˃ Internationalization of national successful products ˃ Optimization in distribution , e.g establishment of a logistics and distribution center in Dubaï in 2013 Reduced costs of sales Risk-adverse strategy 81 » Dependance on individual countries ˃ Germany : + Discount agreements from public health insurance organisations + 67% of sales: generics produced by 3 subsidiaries » Debts ˃ Dependance on long-term liabilities 82 83 » Dependance on individual countries ˃ Germany : + discount agreements from public health insurance organisations + 67% of sales: generics produced by 3 subdisdiaries of the Group » Debts ˃ Dependance on long-term liabilities » No worldwide distribution of STADA subsidiaries ˃ No subsidiary in America ˃ No subsidiary in Japan 84 » No worldwide distribution of STADA subsidiaries 85 » Development of biosimilar production » New acquisitions 86 » Changed or additional state regulation » Intensive competition ˃ With generic products ˃ Agreements with European health insurance organizations » Strong volability in interest rate ˃ Russian ruble, Serbian dinar, pound sterling » Default risk in Eastern Europe ˃ Impact of global economic crisis ˃ CIS economic crisis and restrictions against Russia 87 Most of production locations are in Eastern Europe ! STRENGHTS » Adapted to long-term growth potential markets » Organic growth expected for Branded Products » Cost-effective production WEAKENESSES » Dependance on individual countries » Debts » No worldwide distribution of subsidiaries OPPORTUNITIES » Biosimilar development » New acquisitions THREATS » » » » » Changed state regulation Intensive competition Default risk in some markets Strong volability in interest rate CIS crisis 88 89 90