Orion Building well-being

Orion Building well-being
Anne Allo & Sirpa Pelttari / Orion Corporation

Your primary source for what Orion is about:
Suomeksi: In English: Anne Allo & Sirpa Pelttari / Orion Corporation

Basics about Orion Name: Orion Oyj / Orion Corporation
Businesses: pharmaceuticals (94%) and diagnostic tests (6%) Deep roots in Finland: Established in 1917 as ‘Lääketehdas Orion Oy’, in Helsinki. Re-established in 2006 after a demerger of the former Orion Operational locations in Espoo, Turku, Kuopio, Hanko and Oulu European-wide presence with over 20 marketing companies under names Orion Pharma and Orion Diagnostica Products About 300 medicines and self-care products (Orion Pharma) Active pharmaceutical ingredients, API (Fermion) Diagnostic tests (Orion Diagnostica) Market leader in Finland with 10% market share Recognised world-wide as a specialist in Parkinson’s Disease Listed on Nasdaq OMX Helsinki President & CEO: Timo Lappalainen Anne Allo & Sirpa Pelttari / Orion Corporation

Some figures Anne Allo & Sirpa Pelttari / Orion Corporation

Orion in the light of key figures
2010 2009 Net sales, EUR million 850 772 International operations, % of net sales 73% 71% Operating profit (EBIT), EUR million 254 207 EBIT % of net sales 30% 27% R&D expenses, EUR million 86 95 R&D % of net sales 10% 12% Employees at the year-end 3 131 3 147 In terms of net sales, Orion ranks nr. 78 among global pharma. The figures for 2011 will be disclosed on 7 February 2012. Anne Allo & Sirpa Pelttari / Orion Corporation

Net sales are generated mainly in Europe Breakdown of the EUR 850 million net sales for 2010
By business division By market area Sales through partners 29% Anne Allo & Sirpa Pelttari / Orion Corporation

Half of Orion shares are held by Finnish households
By number of shares By number of votes Financial and insurance corporations 1% Financial and insurance corporations 1% Non-profit Organisations 6% Non-profit Organisations 7% Public sector 4% Public sector 7% Private corporations 8% Households 50% Households 65% Private corporations 14% Foreign held and nominee registered 31% Foreign held and nominee registered 6% Altogether million shares and over shareholders. Both share classes are listed on NASDAQ OMX Helsinki since 1 July 2006– Share A (ORNAV) has 20 votes/share and Share B (ORNBV) has 1 vote/share, in the AGM but they have equal rights to assets and dividends. The market value of Orion Corporation at 31 December 2011 was about 2.2 billion €. Anne Allo & Sirpa Pelttari / Orion Corporation

Broad product portfolio. Some might be familiar to you.

Medicines ’over-the-counter’

Nutritionals Anne Allo & Sirpa Pelttari / Orion Corporation

Non-medicinals, for personal care and hygiene

Pharmacy cosmetics Anne Allo & Sirpa Pelttari / Orion Corporation

For your pet Anne Allo & Sirpa Pelttari / Orion Corporation

Easyhaler® for inhaled asthma medicines

Some background about world pharma industry

Some facts about the pharmaceutical industry 1(2)
World sales 2010 IMS Health: USD 875 bn in wholesale value Big multinationals and local players 10 biggest companies make 40% of the world total. (Pfizer, Sanofi, Merck (US), Novartis, GSK, Roche, AstraZeneca, J&J, Lilly, Abbott) Important role in healthcare Safe, effective and better - and affordable - medicines. Education of healthcare professionals Innovation Average R&D investment is 10-15% of net sales. The solutions to unmet medical needs are explored in companies, with little if any public financing. High regulation High product responsibility. Compliance with Good Practices (GxP) in manufacturing, laboratory, R&D and marketing. Anne Allo & Sirpa Pelttari / Orion Corporation

Some facts about the pharmaceutical industry 2(2)
Products registered & authorised All medicines shall be officially approved for marketing and clinical use. National lists. Restrictions on communication All promotional activities of prescription medicines are addressed to healthcare professionals exclusively. No consumer advertising on prescription medicines. Sales arguments must be based on approved product characteristics (= confirmed study results). Retail sales through pharmacies In most countries, medicines are only available via pharmacies. Challenge of counterfeits Counterfeit (falsified, fake) drugs are an increasing global challenge. Trade in internet is very difficult to control. Anne Allo & Sirpa Pelttari / Orion Corporation

How are we planning to manage?
Orion’s strategy How are we planning to manage? Anne Allo & Sirpa Pelttari / Orion Corporation

Orion concentrates own operations within Europe
Scandinavia Strong domestic market position Western and Central Europe Strong position with proprietary products Eastern Europe Presence with branded generics Southern Europe Progress with proprietary products in hospital markets Finland Market leadership Anne Allo & Sirpa Pelttari / Orion Corporation

Strategic aim: Profitable growth and increased shareholder value whilst keeping business risks under control Partners and networking Flexible and efficient operations Competitive product portfolio Strengthening market position in Europe M ANAGEMENT OF COMPLEXITY IN COST-EFFICIENT WAYS Anne Allo & Sirpa Pelttari / Orion Corporation

Networking and partnering throughout the value chain
R&D R&D partnerships and networks cover all phases from preclinical to product registration Balances risks and enables an increasing number of new research projects Supply Chain Supply Chain operations are global and partnerships cover the whole chain of operations Improved efficiency by “make or buy” decisions Sales & Marketing Partnerships in sales and marketing ensure a broad network of distribution channels Orion’s proprietary drugs distributed worldwide Product portfolio expanded by selling partners’ products Anne Allo & Sirpa Pelttari / Orion Corporation

We invest in R&D to build our future and to fight illnesses
R&D is part of our mission to build well-being Anne Allo & Sirpa Pelttari / Orion Corporation

Our main product looks simple, doesn’t it
Our main product looks simple, doesn’t it? … But its road to market took over 10 years. Anne Allo & Sirpa Pelttari / Orion Corporation

It’s all about an ideal molecule
The active substance in a medicine is like a key in a lock: it either opens or closes a pathway, activates or blocks its target, typically a receptor in a cell. Entacapone, Orion’s drug discovery, acts on COMT, a very common enzyme present in the body. Anne Allo & Sirpa Pelttari / Orion Corporation

The 7-17 year-long road of a molecule candidate to a new drug
”Pipeline” Target identification and validation 8–24 months Lead Molecule 12–24 months optimisation 18–36 months Molecule candidate selection, preclinical dev. Clinical Phase I in healthy humans 12–14 months Clinical Phase II in a small number of real patients 12–36 months Clinical Phase III in a large number of real patients 18–48 months Late stage development Early development Research A partner company may join the work at any stage of the project In the R&D process, the compound’s efficacy as a treatment option for the target disease and safety for the patient are explored with a purpose to confirm the compound’s superiority to already existing medicines. Each step is subject to approval of medicinal authorities (FDA or EMA). The hundreds of parallel and sequential studies generate an enormous documentation of detailed data. If successful, the results are filed into a marketing application to EMA and/or FDA. The review of the application takes 1-2 years. If OK, a marketing authorisation is granted. The compound is patented at an early stage. The protection expires after 20 years. Anne Allo & Sirpa Pelttari / Orion Corporation

Pharmaceutical R&D takes:
Patience One molecule in a million shows some promise. Only completely new drugs (NCEs/NBEs) are approved/introduced annually Time It takes at least 10–15 years to develop a completely new drug from idea to market Money The average cost of developing a new drug is USD 700 million. The risk of failure is high Expertise Ca scientists and other industry staff members are engaged in pharma R&D in the EU alone Anne Allo & Sirpa Pelttari / Orion Corporation

Pharmaceutical R&D also gives:
New treatments Every new treatment gives more hope to manage with a disease. For the patients and their caregivers it also means improved quality of life. Knowledge Understanding of diseases and their mechanisms accumulates with every single study. Even failed projects add our knowledge. Money The R&D investment generates earnings some years after the new product’s launch. Healthcare economics Effective medicinal treatments may save expensive days at hospital, e.g. Innovation Discoveries generate more disoveries to solve unmet medical needs of challenging diseases. Anne Allo & Sirpa Pelttari / Orion Corporation

Orion’s R&D activity Orion is one of Finland’s biggest investors in R&D R&D costs are ca. 10% of our net sales Research staff accounts for 20% of our total workforce Our purpose is to introduce new innovative treatments to global markets Since late 1980’s we have developed 7 molecules into commercialised medicines. They now generate 50% of our net sales We currently explore new medicinal approaches for: central nervous system disorders cancer critical care respiratory diseases (inhalable drugs) Anne Allo & Sirpa Pelttari / Orion Corporation

Proprietary products generated 50% of Orion’s net sales for 2010
Indication EUR million 2010 Stalevo®, Comtess® and Comtan® (entacapone) Parkinson’s Disease 253 Simdax® (levosimendan) Severe heart failure 40 Easyhaler® product family (beclomethasone, budesonide, formoterol) Asthma, COPD 28 Dexdor® and Precedex® (dexmedetomidine) Sedative for patients in intensive care 27 Dexdomitor®, Domitor®, Domosedan® and Antisedan® (dexmedetomidine, detomidine, atipamezole ) Animal sedatives 24 Divina® range (estrogen) Menopausal symptoms 13 Fareston® (toremifene) Breast cancer 12 Total 397 % of pharmaceutical net sales 49 % Anne Allo & Sirpa Pelttari / Orion Corporation

Some helpful terms OTC product (over the counter)
Can be bought without doctor’s prescription Proprietary product A medicine developed in-house all the way throughout the pipeline. The originator holds full rights for the product until patent expiry. Generic medicine Off-patent. A medicine whose patent has expired. Can be copied by anyone. NCE, NBE New Chemical (Biological) Entity. An active substance based on a completely new chemical or biological mechanism of action API Active Pharmaceutical Ingredient, the substance that induces the medicinal effect of the drug Marketing authorisation (MA) The license granted by a medicinal authority (FDA, EMA, Fimea, e.g.) to sell a drug Pipeline New drug development process all the way through preclinical and clinical phases Anne Allo & Sirpa Pelttari / Orion Corporation

Orion and the environment
Sirpa Pelttari Anne Allo & Sirpa Pelttari / Orion Corporation

Environmental legislation: important acts, decrees and decisions for Orion
Environmental protection act /86 Act on Changing the Environmental Protection Act 647/2011 enters into force Environmental Protection Decree /169 Old Waste Act 1072/1993 New Waste Act 646/2011 enters into force on Waste Decree 1390/1993 VOC Decree 435/2001, Government Decree on the limitation of emissions of volatile organic compounds due to the use of organic solvents in certain activities and installations Government Decree on Substances Dangerous and Harmful to the Aquatic Environment 1022/2006 Government decison on information to be provided on hazardous waste and the packing and labelling of hazardous waste 659/1996 Ministry of the Environment Decree on the list of the most common wastes and of hazardous wastes 1129/2001 Chemicals Act 744/1989 Nature Conservation Act 1096/1996 Anne Allo & Sirpa Pelttari / Orion Corporation

Environmental Protection Act
General principles provided in Section 4 for activities that pose a risk of pollution: Pollution prevention and minimizing harmful impact: harmful environmental impact shall be prevented or, when it cannot be prevented completely, reduced to a minimum Caution and care: proper care and caution shall be taken to prevent pollution as entailed by the nature of the activity, and the probability of pollution, risk of accident and opportunities to prevent accidents and limit their effects shall be taken into account Best available techniques, BAT: the best available technique shall be used Best environmental practice: combinations of various methods, such as work methods, shall be used and such raw materials and fuels shall be selected as provide appropriate and cost-efficient means to prevent pollution ‘Polluter pays’: It is the duty of parties engaged in activities that pose a risk of pollution to prevent impact and eliminate or minimize harmful environmental effects Anne Allo & Sirpa Pelttari / Orion Corporation

General duties provided in Section 5 Knowledge requirement: Operators must have sufficient knowledge of their activities' environmental impact and risks and of ways to reduce harmful effects Obligation to prevent pollution: If the activities cause or may directly result in environmental pollution, the operator must take the appropriate action without delay in order to prevent pollution, or, if pollution has already resulted, to reduce it to a minimum (385/2009) In addition, the general duties and principles laid down Chapter 2 of the Waste Act (646/2011) must be observed in activities posing a risk of pollution. (647/2011) Anne Allo & Sirpa Pelttari / Orion Corporation

General permit requirement provided in Section 28: Environmental permit: A permit is required for activities that pose a threat of environmental pollution. Activities subject to a permit are prescribed in more detail by decree. Anne Allo & Sirpa Pelttari / Orion Corporation

New Waste Act 2011 The new Waste Act and ca. 20 other acts linked to it were confirmed on Those acts will enter into force on The acts have been published in Statutes of Finland (Suomen säädöskokoelma), numbers /2011. The purpose is to harmonise the waste legislation in line with today’s waste and environmental policies and the requirements of EU legislation. Anne Allo & Sirpa Pelttari / Orion Corporation

Waste hierarchy A waste hierarchy which complies with the EU Waste Directive (2008/98/EC) and specifies the priority of measures concerning the amount of waste, harm mitigation, and waste management: Preventing the emergence of waste Re-using items as such, e.g. metal barrels Recycling waste as material, e.g. polyethylene plastic Utilising waste as energy; energy waste is combustible waste Safe landfill disposal of waste Waste that cannot be disposed of by other means, e.g. grease trap sludge Anne Allo & Sirpa Pelttari / Orion Corporation

Orion operates under environmental permits
Environmental permits are required for Orion’s pharmaceutical manufacturing operations, as specified in the Environmental Protection Decree of Finland. The environmental permits are granted and supervised by regional environmental authorities. Anne Allo & Sirpa Pelttari / Orion Corporation

Orion’s main site and headquarters are in Espoo
Orion’s site in Espoo is located in Mankkaa, next to the Tapiola sports park. About half of the Group’s employees work here. Anne Allo & Sirpa Pelttari / Orion Corporation

Orion’s Turku site Orion’s manufacturing operations in Turku include certain tablets, hormonal products, cancer medicines and basic ointments. A major research centre is here too. Anne Allo & Sirpa Pelttari / Orion Corporation

Fermion’s Hanko plant Fermion is a so-called fine chemicals manufacturer. It produces active ingredients for pharmaceuticals in chemical synthesis at its plants in Hanko and Oulu. Anne Allo & Sirpa Pelttari / Orion Corporation

Orion’s environmental activities
Our environmental management focus is on the following areas: Waste and materials management Air and soil protection Energy and water consumption Wastewater Environmental burden of our products We monitor the environmental impacts of our operations by e.g measuring and calculating the volumes of chemicals, solvents and other substances, consumption of packaging materials, water and energy, emissions into water and air and keeping track of waste and recording waste statistics. Anne Allo & Sirpa Pelttari / Orion Corporation

ISO 14001 based system under construction
Orion wants to overperform the minimum requirements set by laws and regulations for environmental affairs Orion publishes GRI-compliant Sustainability Reports since The ones for 2009 and 2010 are accessible at Our management approaches and performance indicators of environmental responsibility are presented here. An ISO based environmental management system is currently being built for Orion, first comprising the pharmaceutical preparations business (Espoo, Turku and Kuopio plants). More systematic practices and continuous improvement in environmental affairs An Environmental Policy will be confirmed for Orion in Q1/2012. Anne Allo & Sirpa Pelttari / Orion Corporation

Orion’s current environmental engagements
Responsible Care (RC) Orion is a member of Responsible Care, the global voluntary initiative under which chemical industries work together to continuously improve their health, safety and environmental performance. Environmental performance is reported annually to RC Energy Efficiency Programme of EK As a member in the Energy Efficiency Programme initiated and coordinated by the Confederation of Finnish Industries (EK)Orion aims to cut its proportional energy consumption by 9 per cent by 2016, compared with the 2005 level. This includes the consumption of electricity, heating energy and fuels. Carbon Disclosure Orion reports its CO2 emissions to the Carbon Disclosure Project, CDP Anne Allo & Sirpa Pelttari / Orion Corporation

Orion’s environmental impacts
The manufacturing processes of pharmaceutical products, active pharmaceutical ingredients (API) and diagnostics products differ very much from each other. Accordingly, they also consume materials and generate emissions and waste differently both in terms of amounts and types. Common to all is Uncompromised cleanliness Massive air conditioning systems Anne Allo & Sirpa Pelttari / Orion Corporation

Absolute cleanliness is a must

Water consumption and discharges
Water discharges Orion is a heavy user of water. Most of the water goes to washing the production equipment. The waste waters from are drained to municipal treatment plants in accordance with agreements with environmental authorities. Fermion’s Hanko plant has its own water purification plant where waste water is pre-treated before drained to the municipal treatment system. Anne Allo & Sirpa Pelttari / Orion Corporation

Solid waste Orion monitors its waste volumes using three indicators:
hazardous waste to be transported for disposal recovered waste to be recycled, including energy waste and landfill waste All such solid waste as contains pharmaceuticals is classified as hazardous waste and is sent to Ekokem Oy at Riihimäki Fermion produces the relatively largest amount of Orion’s total hazardous waste The Espoo, Turku and Kuopio operations produce mostly non-hazardous recyclable materials and landfill waste. About 20% of their total solid waste is hazardous. Orion aims to reduce waste by all applicable means. Anne Allo & Sirpa Pelttari / Orion Corporation

Orion’s objectives in waste management
Orion's objectives to reduce the production of waste are aligned with the priority targets specified in the EU-level waste strategy (waste hierarchy of the Directive 2008/98/EC on waste, Waste Framework Directive), which are included in the New Waste Act. Avoiding the production of waste by all possible means Efficient sorting and recycling of the produced waste materials Hereby we also decrease the cost of waste. Seeking ways to re-use materials Minimised landfill waste. Anne Allo & Sirpa Pelttari / Orion Corporation

Emissions into air Since 2007, companies in Finland have had to comply with very stringent emission limits for VOC quantities and concentrations. (Government Decree on the limitation of VOC emissions due to the use of organic solvents in certain activities and installations, 435/2001 at the end of October 2007) Orion’s VOC emissions come from several solvents used by Fermion in its chemical synthesis processes, and mainly ethanol used in tablet mass production and tablet coating in the Turku and Espoo plants Fermion accounts for ca. 97% of the total solvents used by Orion, and for about 75% of Orion’s total VOC emissions. Thanks to process investments in Hanko and Oulu, Orion’s total VOC emissions dropped dramatically from 2007 (in 2010 we experienced some technical problems at Fermion’s Oulu plant). Very small amounts of dust. Combustion gases from the steam boiler of Espoo and Kuopio. The sulphur content of the oil is low (less than 1%) CO2 emissions are reported for direct and indirect energy comsumption Anne Allo & Sirpa Pelttari / Orion Corporation

Environmental challenges for Orion to cope with
We try to minimize the use of volatile organic solvents by changing processes. We are studying possibilities to burn the volatile solvents that evaporate from the tablet manufacturing processes and get mixed with the outlet air. Today, more than 90% of the volatile solvents in the plants of Espoo and Turku pass through the gas scrubbers into waste waters. An important goal for Orion is to continuously reduce emissions in the waste water and particularly the amount of harmful substances in them. The means to achieve this include more efficient pre-cleaning of the manufacturing equipment. Even better control of energy and water consumption (heat recovery systems, e.g.). Anne Allo & Sirpa Pelttari / Orion Corporation

Orion building environmental well-being with HH students

The world’s top 20 pharmaceutical companies
1-10 Pfizer Sanofi Merck & Co Novartis GlaxoSmithKline Roche AstraZeneca Johnson&Johnson Eli Lilly & Co Abbott Anne Allo & Sirpa Pelttari / Orion Corporation

The world’s top 20 pharmaceutical companies
11-20 Bristol-Myers Squibb Teva Amgen Bayer Takeda Boehringer Ingelheim Astellas Novo Nordisk Daiichi Sankyo Eisai Anne Allo & Sirpa Pelttari / Orion Corporation

Finland’s top 20 pharmaceutical companies
1-10 Orion Pfizer (MSD) ( ) fuusio US-Merckin kanssa GlaxoSmithKline AstraZeneca Sanofi Novartis Roche Leiras Abbott Anne Allo & Sirpa Pelttari / Orion Corporation

Finland’s top 20 pharmaceutical companies
11-20 Novo Nordisk Ratiopharm Bayer Schering Lilly Boehringer Ingelheim Janssen-Cilag Amgen Actavis Lundbeck Baxter Anne Allo & Sirpa Pelttari / Orion Corporation

These companies are also interesting ones
Merck KGaA Shire Leo Pharma Santen Meda Indian pharmaceutical companies Sun Dr Reddy’s Wockhardt Aurobindo Ranbaxy Torrent Anne Allo & Sirpa Pelttari / Orion Corporation

Contact Anne & Sirpa Anne Allo Corporate Responsibility Officer Orion Oyj | Orion Corporation P.O.Box 65, Espoo Orionintie 1 A, Espoo Sirpa Pelttari EHS Specialist Orion Oyj | Orion Corporation P.O.Box 65, Espoo Orionintie 1 A, Espoo Anne Allo & Sirpa Pelttari / Orion Corporation

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Orion Building well-being

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