CM presentation 2020 Orion today year 2018 in figures Sales by - PowerPoint PPT Presentation

CM presentation 2020

Orion today — year 2018 in figures Sales by business Sales by market area Net sales 977 MEUR Operating profit 253 MEUR 5% 4% 15% 7% 34% 32% Personnel ~ 3 200 6% R&D investments 104 MEUR 50% 31% 16% 6 production sites in Finland Own sales unit in 26 European countries You can rely on us - Orion Contract Manufacturing

Our businesses Proprietary Products Specialty Products In-house developed drugs and Generic prescription drugs, OTC and other drugs with valid product non-medicinal products, biosimilars protection Animal Health Fermion Medicine and well-being Active pharmaceutical products for animals ingredients (APIs) Contract Manufacturing Manufacturing and packaging services for other pharmaceutical companies You can rely on us - Orion Contract Manufacturing

Orion has operations in 27 countries • HQ • Research & development Finland • Six production sites • Sales unit • Support functions • Sales unit UK • Research & development Europe • Sales unit in 26 countries India • Support functions • Global partner network ROW for sales You can rely on us - Orion Contract Manufacturing

Orion Manufacturing Operations in Finland  Turku Plant | ~500 SC and QM employees Oulu Fermion plant | ~100 employees  API synthesis development & production Dosage forms  Hormone gels & solutions Kuopio Plant | ~50 SC and QM employees  Tablets & capsules Dosage forms  Potent & cytotoxic tablets & capsules  Non-sterile liquids, suspensions  Creams & ointments  Nasal & topical sprays, drops  Rectal enemas Oulu Salo Plant | ~110 SC and QM employees Espoo Plant | ~730 SC and QM employees  Centralized warehouse Dosage forms  Tablet packaging  Liquid small-volume parenterals Kuopio  Serialization (vials & ampoules)  Tablets & capsules Hanko Fermion plant | ~160 employees TurkuSalo  Inhalations Espoo  API synthesis development & production Hanko You can rely on us - Orion Contract Manufacturing

We know the importance of keeping a promise. It is the reason why we have been over 100 years in the business. You can rely on us.

If you are looking for a partner who... Delivers Helps with high reliability you to get your product throughout product life cycle from development to the market WE OFFER WE OFFER • Established and highly developed processes • Upscaling product to commercial stage and technologies • Wide expertise throughout the whole value • Approvals of global regulatory bodies and chain long track record of inspections • Diverse production and process capability • On-time delivery reliability as your needs grow • Sustainability, CSR and EHS practices well • Tailor-made complex solutions in place • Our established processes to Customers • Our experience to Customers You can rely on us - Orion Contract Manufacturing

You can rely on us. 99,5 % Compliance On-time delivery FDA, EMA, JP , ANVISA, performance TGA, Korean FDA, Russia etc. You can rely on us - Orion Contract Manufacturing

Prepare while others are daydreaming. Finnish airports run throughout year despite the hard weather conditions in winter. That constant performance is not a matter of luck, it is a matter of high standards and good preparation. That is in our heritage as well. We prepare to maintain good service level. You can rely on us - Orion Contract Manufacturing

Secure your supply chain Protect your IP Protect your product Protect your reputation Ensure your supply chain ethics Finland is like this bedrock • One of the least corrupted countries • The best adult literacy skills in EU No hurricanes, floods or • earthquakes • Stable politics and currency • Well-established legislation and infrastructure You can rely on us - Orion Contract Manufacturing

Our main approvals (FDA & EMA) track record 2000 1990 2010 2020 ESPOO TURKU KUOPIO SALO (EST. 2014) You can rely on us - Orion Contract Manufacturing

Our latest GMP inspections and audits Authority Espoo plant Turku plant Kuopio plant* Salo plant FDA 2018, 2016, 2014 2016, 2014, 2013 2015 EMA 2018, 2017, 2015 2017, 2014, 2011 2019, 2013, 2010 2019, 2018, 2015 ANVISA 2017, 2014, 2008 2018, 2012, 2007 2016 MOH, Russia 2017,2020 2018, 2017, 2020 2017, 2020 Korean FDA 2009 2013 MOH, Turkey 2018, 2012 2012 2018, 2016 Taiwan 2013 Belarus 2018 2018 PMDA Accredited Accredited Accredited You can rely on us - Orion Contract Manufacturing

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 Energy savings Audits undertaken Energy Customer Injury rate target set for 2025 by Orion savings complaints achieved (Pharmaceuticals) 56 238 5.5 1,074 40% Ppm (64) (314) MWh (3,725) (31%) LTIF 1 (6.3) You can rely on us - Orion Contract Manufacturing 13

In 2017 there were fewer product recalls than in the year before, number of audits increased Audits by 3rd Audits Product by Orion parties recalls 13 81 10 314 4 55 269 3 ● No critical observations in audits 4 carried out by authorities, 6 customers and partners. 29 26 4 1 1 ● Slightly less critical observations than in the previous year in 2016 2017 2016 2017 2016 2017 audits carried out by Orion on GxP audits Non-medicinal product GxP and EHS partners. audits, partners EHS audits Class 3 (minor) and customers ● No product recalls related to Critical observations Class 2 (major) GxP and EHS critical defects (Class 1). audits, authorities Class 1 (critical) You can rely on us - Orion Contract Manufacturing

Production capabilities and expertise You can rely on us - Orion Contract Manufacturing

Orion Contract Manufacturing Hormonal Gels Semisolids Cytotoxics Packaging and and Solutions Serialization APIs and Liquid Intermediates Forms Special Capabilites Sterile Solutions Solid Oral  High potent Dosage Forms Veterinary  products You can rely on us - Orion Contract Manufacturing

Hormone production BATCH SIZES EQUIPMENT DOSAGE FORMS PROCESSING • Becomix Mixing • Solutions • • 120-2000 Liters Krieger • • Gels • Homogenisation • Fryma • Creams • OEL-5 PRODUCTION FACILITY PACKAGING • 8000 m² of new manufacturing, packaging, technical and supporting • Alu/Laminate Sachets areas • Pump Bottles • Dedicated area for storing, weighing and dispensing of potent APIs Sprays • • Suitable for handling of large volumes of flammable liquids Tailor-made • • Closed processes, isolators and glove boxes • Controlled removal of wastes You can rely on us - Orion Contract Manufacturing

Sterile production BATCH SIZES PROCESSING DOSAGE FORMS • Aseptic Manufacturing & Injectable • • 20-580 Liters Filling Solutions • • Terminal Sterilization OEL-4/5 • EQUIPMENT PACKAGING Bosch • • Glass Vials 5-50 ml Bausch & Ströbel • Ampoules 1-20 ml • • Eisai (Inspection) Blister Packaging • • Nikka (Inspection) You can rely on us - Orion Contract Manufacturing

Semi-solid forms DOSAGE FORMS PROCESSING BATCH SIZES • Mixing Ointments • • 80/300 -1000 kg • Homogenisation • Creams & Gels • OEL-4/5 • Solutions PACKAGING EQUIPMENT • Fryma • Alu/Plastic/Polyfoil Tubes Plastic Pump • Krieger Bottles • Nordenmatic Oral Syringes • Groninger • • Rectal Tubes King • • Nasal & Topical Sprays You can rely on us - Orion Contract Manufacturing

Cytotoxics production DOSAGE FORMS PROCESSING BATCH SIZES 15/70 -140 Kg Tablets Film- & Uncoated • Dry Mixing • • • Isolators • Capsules Hard Gelatin OEL-5 • EQUIPMENT PACKAGING Fielder • • Plastic Jars • Lödige • Fette • Accela Cota You can rely on us - Orion Contract Manufacturing

Liquid forms production DOSAGE FORMS PROCESSING BATCH SIZES • Mixing Solutions • 80-6000 kg • • Homogenisation • Drops • Filtering • Suspensions Isolators • • Nasal & Topical Sprays (Telstar) PACKAGING EQUIPMENT Bausch & Ströbel Glass Bottles • • • Uhlmann • Plastic Bottles • Bosch • Nasal Spray Bottles • FrymaKoruma IKA • You can rely on us - Orion Contract Manufacturing

Solid oral dosage forms DOSAGE FORMS PROCESSING BATCH SIZES • High shear & fluid bed Tablets filmcoated/ • 100-1700 • granulation, FB drying uncoated/modified Kg Spheronization • release Dry mixing • Capsules, hard gelatin • OEL-4 EQUIPMENT PACKAGING Blisters • Fielder Lödige • • • Glass Jars Glatt Fette • • • Plastic Jars • GEA • Manesty • Square and round bottles You can rely on us - Orion Contract Manufacturing