1*/. Orion’s Annual Report 2008 Dear reader, Orion’s Annual Report 2008 comprises two sections: Company Brochure and Financial Statements. The Brochure section includes a Well-Being Guide with tips for a healthier life. The Company Brochure discusses Orion as a company, including the business divisions, R&D activities and corporate responsibility. The Financial Statements section also includes special information for investors. Once again, Orion’s employees have teamed up to promote Orion’s mission to build well-being. This is also the theme of the Annual Report. The Well-Being Guide shows us how to enjoy the pleasures offered by work, health, family and leisure that are available to us every day. Read more about Orion on these pages and browse through the provided links DID YOU KNOW THAT for more information. Orion's logo is derived Enjoy! from the shape of the retort, a glass bottle used for distillation in a chemistry laboratory. Contents ORION AS A COMPANY 2 Orion in brief 4 Year in brief 6 President and CEO’s Review 8 Strategy 12 Business environment 14 Orion’s approach 18 Orion on the map DIVISIONS 22 Divisions in brief 24 Proprietary Products 26 Specialty Products 28 Animal Health 30 Fermion 32 Orion Diagnostica RESEARCH AND DEVELOPMENT 36 Research and development 40 Drug discovery and development RESPONSIBILITY 44 Responsibility for tomorrow 45 Stakeholder communication 46 Personnel 50 Environment FINANCIAL STATEMENTS AND GOVERNANCE 54 Board of Directors 56 Executive Management Board 60 Financial Statements Orion’s Annual Report 2008 2 Orion in brief Orion's Annual Report 2008 Orion in brief 3 Orion is an innovative European R&D-based pharmaceuticals and diagnostics company with an emphasis on developing medicinal treatments and diagnostic tests for global markets. Orion in brief Orion is an innovative European R&D- Orion’s products are available in over one Research and development based pharmaceuticals and diagnostics hundred countries. Orion has operations company with an emphasis on devel- in 19 countries, employing about 3,100 Orion carries on intensive research with oping medicinal treatments and diag- professionals. In 2008, the company’s the aim of introducing innovative new nostic tests for global markets. Orion net sales amounted to EUR 710.7 million. medicinal treatments to global markets. develops, manufactures and markets Operating profit was EUR 185.0 million. The focus of Orion's research and devel- human and veterinary pharmaceuticals, Orion’s shares are listed on NASDAQ opment strategy is on three core therapy active pharmaceutical ingredients as well OMX Helsinki (Orion Corporation: areas: central nervous system, oncology as diagnostic tests. ORNAV and ORNBV). The company’s and critical care, and respiratory products auxiliary business names include Orion for Orion's proprietary device Easyhaler. Orion’s customers are mainly healthcare Pharma, Fermion and Orion Diagnostica. service providers and professionals such Read more about R&D on pages 36 – 41. as doctors, vets, pharmacies, hospitals, Read more about year 2008 on pages 4 – 5. healthcare centres, clinics and laborato- Read more about strategy on pages 8 – 11. Business segments ries. Consumers and pet owners consti- tute another important customer group. Orion has two business segments: the Pharmaceuticals business and the Diagnostics business. Two business segments and The Pharmaceuticals business segment five business divisions researches, develops, manufactures and markets pharmaceuticals and active pharmaceutical ingredients. The Proprietary ∧ Patented prescription products Pharmaceuticals business comprises the focus on 3 core therapy areas: Products Central Nervous System, following divisions: Oncology and Critical Care, Easyhaler â Proprietary Products – patented pre- 40% scription products â Specialty Products – off-patent pre- scription drugs and self-care products Specialty Products ∧ Generic, off-patented prescription products and self-care products â Animal Health – veterinary products for pets and production animals 36% â Fermion – active pharmaceutical ingredients Animal Health ∧ Veterinary products for pets and The Diagnostics business segment production animals 9% develops, manufactures and markets Fermion ∧ Active pharmaceutical ingredients 5 diagnostic tests. The business comprises % one business division: ∧ Diagnostic tests Orion Diagnostica 6% â Orion Diagnostica – diagnostic products Other ∧ Contract manufacturing for other Read more about divisions on pages 22 – 33. companies 4% www.orion.fi Orion’s Annual Report 2008 4 Year in brief Events in 2008 january timo lappalainen took over as february orion published its financial state- President and CEO of Orion. ments for 2007. The company’s financial 1 7 performance remained good. april orion announced that it had acquired april based on the favourable results European-wide marketing rights to the received from the FIRST-STEP study, prostate cancer drug Vantas® from the Orion initiated a process for expanding 4 US-based Indevus. 15 the indication for the Parkinson’s disease drug Stalevo® in the USA and Europe. april interim report 1 – 3/2008 was published. may orion announced its decision The key figures were strong. to discontinue the development of a new COMT inhibitor candidate 25 9 at the end of clinical Phase I. may orion announced that it had acquired june co-operation with the Swedish com- marketing rights to Kentera® from the pany Oasmia was extended to veterinary Italian company Recordati. Kentera medicines through a licensing agreement 30 is indicated for urge incontinence and 25 for marketing Paccal®, a skin cancer drug overactive bladder. being developed for dogs. august interim report 1 – 6/2008 was published. september orion received exclusive rights to market Steady growth continued. an extensive portfolio of Pfizer's veterinary 5 29 medicines in Scandinavia. october interim report 1 – 9/2008 was published. november orion announced plans to renew Net sales were higher compared with the its operational model for pharmaceutical previous year. R&D. The related negotiations with 28 19 personnel representatives may lead to a reduction of jobs in Finland. In 2008, Orion had to defend its patents. ANDAs were filed in the USA on generic versions of Stalevo and Comtan. Therefore, Orion filed patent infringement lawsuits against the Wockhardt and Sun companies. By virtue of the legal proceedings, the realisation of generic competition regarding these products is neither certain nor imminent. More information on these and other events is available at www.orion.fi Orion’s Annual Report 2008 Year in brief 5 The products resulting from Orion’s in-house R&D accounted for 46% of the pharmaceutical 46% net sales. Orion’s result Orion’s net sales in 2008 were EUR 710.7 The Orion Group’s net sales in 2008 were The Orion Group’s operating profit in million (EUR 680.0 million in 2007), up EUR 710.7 million (EUR 680.0 million 2008 was EUR 185.0 (192.0) million, by 4.5% on the comparative year 2007. in 2007), an increase of 4.5% on the down by 3.6% on the comparative year. previous year. The Pharmaceuticals busi- The Pharmaceuticals business had an â Operating profit was EUR 185.0 (192.0) ness had net sales of EUR 667.6 (639.7) operating profit of EUR 188.5 (197.1) million. million, up by 4.4% on the previous million, down by 4.4% on the previous â Profit before taxes was EUR 184.2 year. Products based on in-house R&D year. The Diagnostics business had an (193.4) million. accounted for EUR 307.5 (292.3) million, operating profit of EUR 6.1 (6.3) million. or 46% (46%) of net sales. Net sales â Equity ratio was 60.2% (76.2%). from the Parkinson’s disease drugs R&D expenses amounted to EUR â Return on capital employed (ROCE) Stalevo® and Comtess®/Comtan® 103.4 (98.5) million, up by 5.0% on the before taxes was 38.5% (44.8%). totalled EUR 208.5 (200.1) million, or previous year and accounting for 14.5% about 31% (31%) of the net sales of (14.5%) of the consolidated net sales. â Return on equity (ROE) after taxes was the Pharmaceuticals business. Orion Pharmaceutical R&D accounted for EUR 32.1% (33.5%). Diagnostica’s net sales were EUR 45.0 98.8 (94.2) million of the total. â Earnings per share were EUR 0.97 (42.0) million, up by 7.1% on the previous (1.02). year. The sales of the QuikRead® infec- tion tests continued to grow, but declined â Cash flow per share before financing sales of the older product portfolio was EUR 0.66 (0.92). slowed down overall growth. â Proposed dividend per share is EUR 0.95 (1.00) per share. Net sales by market area 2008 Net sales by business divisions 2008 Key fi gures % % 2008 2007 Net sales, EUR million 710.7 680.0 Operating profi t (EBIT), EUR million 185.0 192.0 % of net sales 26.0 28.2 Profi t before taxes, EUR million 184.2 193.4 Earnings per share (EPS), EUR 0.97 1.02 R&D expenses, EUR million 103.4 98.5 ROCE, % 38.5 44.8 ROE, % 32.1 33.5 Equity ratio, % 60.2 76.2 Finland, 31% Proprietary Products, 40% Gearing, % -7.1 -20.0 Scandinavia, 14% Specialty Products, 36% Personnel at end of the period 3,309 3,176 Other Europe, 34% Animal Health, 9% North America, 10% Fermion, 5% Other markets, 11% Other, 4% Orion Diagnostica, 6% Read more on pages 65 – 73. Orion’s Annual Report 2008 6 President and CEO’s Review Orion’s Annual Report 2008 President and CEO’s Review 7 Cumulative net sales of Parkinson’s disease drugs Stalevo and Comtess/Comtan exceeded EUR 1 billion. President and CEO’s Review Orion had another successful year Towards even more intense networking Preparing for tomorrow in 2008.