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TRANSCRIPT
CM presentation 2018
Orion today — year 2017 in figures (adjusted)
Net sales 1,034 MEUROperating profit 284 MEUR
Personnell ~ 3 200
R&D investments 99 MEUR
6 production sites in Finland
Own sales unit in26 European countries
34%
50%
7%5% 4%
Sales by business
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, Orion Diagnostica business is reported as discontinued operation. The figures for 2017 are adjusted, and do not include Orion Diagnostica.
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Our businesses
Contract Manufacturing
Manufacturing and packaging services for other pharmaceutical companies
Animal Health
Medicine and well-being products for animals
Fermion
Active pharmaceutical ingredients (APIs)
Proprietary Products
In-house developed drugs and other drugs with valid product protection
Specialty Products
Generic prescription drugs, OTC and non-medicinal products, biosimilars
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You can rely on us - Orion Contract Manufacturing
Orion has operations in 27 countries
Finland
• HQ• Research & development• Six production sites• Sales unit• Support functions
UK • Sales unit• Research & development
Europe • Sales unit in 26 countries
India • Support functions
ROW • Global partner network for sales
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Orion Manufacturing Operations in Finland
Espoo Plant | ~730 SC and QM employees
Dosage forms
Liquid small-volume parenterals
(vials & ampoules)
Tablets & capsules
Inhalations
Dosage forms
Non-sterile liquids, suspensions
Nasal & topical sprays, drops
Rectal enemas
Kuopio Plant | ~50 SC and QM employees
Dosage forms
Hormone gels & solutions
Tablets & capsules
Potent & cytotoxic tablets & capsules
Creams & ointments
Turku Plant | ~500 SC and QM employees
Salo Plant | ~110 SC and QM employees
Centralized warehouse
Tablet packaging
Serialization
Hanko Fermion plant | ~160 employees
API synthesis development & production
Oulu Fermion plant | ~100 employees
API synthesis development & production
Oulu
Kuopio
EspooTurku
Salo
Hanko
We know the importance of keeping a promise. It is the reason why we have been 100 years in the business.
You can rely on us.
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If you are looking for a partner who...
Helpsyou to get your product
from development to the market
WE OFFER• Upscaling product to commercial stage
• Wide expertise throughout the whole value chain
• Diverse production and process capability as your needs grow
• Tailor-made complex solutions
Delivers with high reliability
throughout product life cycle
WE OFFER• Established and highly developed processes
and technologies
• Approvals of global regulatory bodies and long track record of inspections
• On-time delivery reliability
• Sustainability, CSR and EHS practices well in place
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You can rely on us.
99,5 %On-time delivery performance in
2017
FDA, EMA, JP, ANVISA, TGA, Korean FDA,
Russia etc.
Compliance
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.
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You can rely on us - Orion Contract Manufacturing
Secure your supply chain
Finland is like this bedrock
• No hurricanes, floods or earthquakes
• Stable politics and currency
• Well-established legislation and infrastructure
Protect your IP
Protect your product
Protect your reputation
Ensure your supply chain ethics
• One of the least corrupted countries
• The best adult literacy skills in EU
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Our main approvals (FDA & EMA) track record
KUOPIO
TURKU
ESPOO
SALO(EST. 2014)
1990 2000 20202010
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Our latest GMP inspections and audits
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Production capabilities and expertise
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Orion Contract Manufacturing
Hormonal Gels and Solutions
Semisolids Cytotoxics Packaging and Serialization
APIs and IntermediatesLiquid
Forms
Special Capabilites High potent Veterinary
products
Sterile Solutions Solid Oral Dosage Forms
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Hormone production
PROCESSING
• Mixing• Homogenisation• OEL-5
DOSAGE FORMS
• Solutions• Gels• Creams
BATCH SIZES
• 120-2000 Liters
EQUIPMENT
• Becomix• Krieger• Fryma
• Alu/Laminate Sachets• Pump Bottles• Sprays• Tailor-made
PACKAGING PRODUCTION FACILITY• 8000 m² of new manufacturing, packaging, technical and supporting
areas• Dedicated area for storing, weighing and dispensing of potent APIs• Suitable for handling of large volumes of flammable liquids• Closed processes, isolators and glove boxes • Controlled removal of wastes
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Sterile production
• Aseptic Manufacturing & Filling
• Terminal Sterilization• OEL-4/5
• Injectable• Solutions
• 20-580 Liters
• Bosch• Bausch & Ströbel• Eisai (Inspection)• Nikka (Inspection)
• Glass Vials 5-50 ml• Ampoules 1-20 ml• Blister Packaging
PROCESSINGDOSAGE FORMS BATCH SIZES
EQUIPMENT PACKAGING
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Semi-solid forms
• Mixing• Homogenisation• OEL-4/5
• Ointments• Creams & Gels• Solutions
• 80/300 -1000 kg
• Fryma• Krieger• Nordenmatic• Groninger• King
• Alu/Plastic/Polyfoil Tubes Plastic PumpBottles
• Oral Syringes• Rectal Tubes• Nasal & Topical Sprays
PROCESSINGDOSAGE FORMS BATCH SIZES
EQUIPMENT PACKAGING
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Cytotoxics production
• Fielder• Lödige• Fette• Accela Cota
• Plastic Jars
• 15/70 -140 Kg• Tablets Film- & Uncoated• Capsules Hard Gelatin
• Dry Mixing• Isolators• OEL-5
PROCESSINGDOSAGE FORMS BATCH SIZES
EQUIPMENT PACKAGING
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Liquid forms production
• Glass Bottles• Plastic Bottles• Nasal Spray Bottles
• 80-6000 kg• Solutions• Drops• Suspensions• Nasal & Topical Sprays
• Mixing• Homogenisation• Filtering• Isolators
(Telstar)
PROCESSINGDOSAGE FORMS BATCH SIZES
EQUIPMENT PACKAGING
• Bausch & Ströbel• Uhlmann• Bosch• FrymaKoruma• IKA
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Solid oral dosage forms
• Fielder• Glatt• GEA
• Lödige• Fette• Manesty
• Blisters• Glass Jars• Plastic Jars• Square and round bottles
• 100-1700 Kg
• Tablets filmcoated/uncoated/modifiedrelease
• Capsules, hard gelatin
• High shear & fluid bedgranulation, FB drying
• Extrusion and spheronizationDry mixing
• OEL-4
PROCESSINGDOSAGE FORMS BATCH SIZES
EQUIPMENT PACKAGING
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Tablet Packaging in Salo
SERIALIZATION
PACKAGES
• Plastic round/square jars• Glass jars • Blister packages• Tailor-made
EQUIPMENT
• Uhlmann
• Systech software • TraceLink repository• Aggregation• Tamper evidence• Semi-manual for special packages• Experience since 2015
FACILITY AND PROCESS
• Site established in 2013 • Each line in in its own dedicated area• Primary & secondary packaging separated in own
cleanliness classes• Humidity & temperature controlled as needed
SERVICESWAREHOUSING
• 14 000 pallet locations • 120 cold storage pallet locations
• QA release • EU reanalyzing • Regulatory support• Logistics management• VMI• Serialization data
management• Launch support• Fluent artwork process
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Special capabilities
• Medical devices
• EU re-analyses & QA release
• Logistics & launch management
• FDA compliant free space
SERVICES VETERINARY PRODUCTS
CONTROLLED SUBSTANCES POTENTS
• License for manufacturing
• All dosage forms
• Oral prefilled syringes
• Schedules I-V
• Fast and easy licensing procedures
• Secure production and logistics
• Potent products up to OEL-5
• Corticosteroids
• Isolators & employee protection
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Fermion – APIs ● One partner for api & drug products
SERVICESRoute scouting, process and analyticaldevelopment and optimization
Commercial manufacturing
Particle engineering and impurity control
APISCDMO for standard and high potencyAPIs both cytotoxic and non-cytotoxic
Complex intermediates
25 generic APIs for the global market
REGULATORY AND COMPLIANCE
Approved by FDA since 1979
High quality, EHS and sustainabilitystandards
EQUIPMENT
Highly automated facilities
Reactor sizes from 10-30 l (R&D) to 60 – 6300 l, total volumeof reactors 320 m3
Hastelloy, stainless steel, glass-lined
Glove boxes for HAPI handling
Buss loop of 500 l for hydrogenations
CONTACT DETAILSTeemu Korhonen, Business Development Manager [email protected]
Japan: Jyrki Lämsä, Manager, Marketing and [email protected]
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Packaging and serialization – We are prepared!
2010 2012
2011 2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Serialization and aggregation2010-2012
Serialization and aggregationstarted in 2011, all medicines in 2016
Serialization- aggregation for special products 2011-2014
Serialization + aggregation of all exported medicines 2014
Serialization in 2015 and aggregation at latest 2017
Serialization2016-2017
Serialization in 2017 and aggregation at latest 2023
Serialization for all EU countries 2019 (except Belgium, Italy & Greece at latest 2024)
On hold
We make your product serialized, tamper proof and child resistant so that you can sell in all your target markets
REGULATORY TIMELINE
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CONTACT US FOR MORE INFORMATION
Jari KaunistoDirector Sales and Marketing Contract Manufacturing [email protected]. +358 50 966 3543
Maria Moukola Business Manager Contract [email protected]. +358 50 966 7162
Visit our web page: www.orion-cmo.fi
Contact us via email: [email protected]
Follow us on LinkedInwww.linkedin.com/company/orion-contract-manufacturing