CM presentation 2019 Orion today year 2018 in figures Sales by - - PowerPoint PPT Presentation

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cm presentation 2019 orion today year 2018 in figures
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CM presentation 2019 Orion today year 2018 in figures Sales by - - PowerPoint PPT Presentation

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CM presentation 2019 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% Personnell ~ 3 200 6% R&D investments 104 MEUR 50% 31% 16% 6

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CM presentation 2019

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Orion today — year 2018 in figures

Net sales 977 MEUR Operating profit 253 MEUR Personnell ~ 3 200 R&D investments 104 MEUR 6 production sites in Finland Own sales unit in 26 European countries

34% 50% 7% 5% 4% Sales by business 32% 16% 31% 6% 15% Sales by market area

You can rely on us - Orion Contract Manufacturing

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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

  • ther drugs with valid product

protection Specialty Products Generic prescription drugs, OTC and non-medicinal products, biosimilars

You can rely on us - Orion Contract Manufacturing

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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

You can rely on us - Orion Contract Manufacturing

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SLIDE 5

You can rely on us - Orion Contract Manufacturing

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 Espoo TurkuSalo Hanko

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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.

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You can rely on us - Orion Contract Manufacturing

If you are looking for a partner who...

Helps

you 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  Our established processes to Customers

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  Our experience to Customers

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You can rely on us - Orion Contract Manufacturing

You can rely on us.

99,5 %

On-time delivery performance

FDA, EMA, JP , ANVISA, TGA, Korean FDA, Russia etc.

Compliance

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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

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SLIDE 10

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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You can rely on us - Orion Contract Manufacturing

Our main approvals (FDA & EMA) track record

KUOPIO TURKU ESPOO SALO (EST. 2014)

1990 2000 2020 2010

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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 2018, 2017 2017 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

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13

Material themes of Orion’s sustainability

LTIF 1 (6.3)

5.5

Injury rate

1,074

Energy savings MWh (3,725)

238

Audits undertaken by Orion (314)

40%

Energy savings target set for 2025 achieved (31%)

56

Customer complaints (Pharmaceuticals) Ppm (64)

  • Patient safety
  • Ensuring reliable supply of medications
  • Manufacturing medications in an

environmentally sustainable way: efficient use of materials, energy efficiency, wastewater management

You can rely on us - Orion Contract Manufacturing

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2016 2017 GxP and EHS audits, partners and customers GxP and EHS audits, authorities

  • No critical observations in audits

carried out by authorities, customers and partners.

  • Slightly less critical observations

than in the previous year in audits carried out by Orion on partners.

  • No product recalls related to

critical defects (Class 1).

In 2017 there were fewer product recalls than in the year before, number of audits increased

55 81

2016 2017 GxP audits EHS audits

29 26

Critical observations

1 4 1 4 6 4 3

2016 2017 Non-medicinal product Class 3 (minor) Class 2 (major) Class 1 (critical)

13 10 269 314 Audits by 3rd parties Product recalls Audits by Orion

You can rely on us - Orion Contract Manufacturing

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You can rely on us - Orion Contract Manufacturing

Production capabilities and expertise

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You can rely on us - Orion Contract Manufacturing

Orion Contract Manufacturing

Hormonal Gels and Solutions Semisolids Cytotoxics Packaging and Serialization APIs and Intermediates Liquid Forms Special Capabilites

  • High potent
  • Veterinary

products

Sterile Solutions Solid Oral Dosage Forms

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You can rely on us - Orion Contract Manufacturing

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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You can rely on us - Orion Contract Manufacturing

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

PROCESSING DOSAGE FORMS BATCH SIZES EQUIPMENT PACKAGING

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You can rely on us - Orion Contract Manufacturing

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 Pump

Bottles

  • Oral Syringes
  • Rectal Tubes
  • Nasal & Topical Sprays

PROCESSING DOSAGE FORMS BATCH SIZES EQUIPMENT PACKAGING

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You can rely on us - Orion Contract Manufacturing

Cytotoxics production

  • Fielder
  • Lödige
  • Fette
  • Accela Cota
  • Plastic Jars
  • 15/70 -140 Kg
  • Tablets Film- & Uncoated
  • Capsules Hard Gelatin
  • Dry Mixing
  • Isolators
  • OEL-5

PROCESSING DOSAGE FORMS BATCH SIZES EQUIPMENT PACKAGING

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You can rely on us - Orion Contract Manufacturing

Liquid forms production

  • Glass Bottles
  • Plastic Bottles
  • Nasal Spray Bottles
  • 80-6000 kg
  • Solutions
  • Drops
  • Suspensions
  • Nasal & Topical Sprays
  • Mixing
  • Homogenisation
  • Filtering
  • Isolators

(Telstar)

PROCESSING DOSAGE FORMS BATCH SIZES EQUIPMENT PACKAGING

  • Bausch & Ströbel
  • Uhlmann
  • Bosch
  • FrymaKoruma
  • IKA
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You can rely on us - Orion Contract Manufacturing

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/modified release

  • Capsules, hard gelatin
  • High shear & fluid bed

granulation, FB drying

  • Spheronization

Dry mixing

  • OEL-4

PROCESSING DOSAGE FORMS BATCH SIZES EQUIPMENT PACKAGING

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You can rely on us - Orion Contract Manufacturing

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

SERVICES WAREHOUSING

  • 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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You can rely on us - Orion Contract Manufacturing

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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You can rely on us - Orion Contract Manufacturing

Fermion – APIs

  • One partner for api & drug products

Contract Manufacturing

  • Production from laboratory scale to

commercial scale

  • 3 manufacturing sites in Finland
  • Total volume of reactors 320 m3
  • GMP reactor sizes vary from 10 l to 6300 l
  • Annual API capacity >400 metric tons
  • High-potency APIs (OEB5) (cytotoxic and

non-cytotoxic) from grams to tens of tons

Contract Development

  • Synthesis development and process

engineering

  • Analytical development and testing
  • Particle engineering
  • Scale-up
  • Validation
  • Lifecycle management

Regulatory and Compliance

DMF compilation, maintenance and consultancy services Experience in regulatory filings in e.g. USA, Canada, EU DMF/CEP, Japan, Taiwan, China, Brazil, Australia FDA approved since 1979 and EMA approved since 1971

Equipment

  • Highly automated facilities
  • Reactor sizes from 10-30 l (R&D) to 60 – 6300 l, total volume of

reactors 320 m3

  • Hastelloy, stainless steel, glass-lined
  • Glove boxes for HAPI handling
  • Buss loop of 500 l for hydrogenations

Inspection history Espoo Hanko Oulu

FDA

2003 2011 2011 2014 2016 2018 2010 2013 2016 2017

FIMEA (Finland)

2010 2013 2017 2011 2014 2017 2011 2014 2017

PMDA (Japan)

2006*

KFDA (South Korea)

2010

ANVISA (Brazil)

2011 2016
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You can rely on us - Orion Contract Manufacturing

Packaging and serialization – We are ready!

2010 2012 2011 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 Serialization and aggregation 2010-2012 Serialization and aggregation started 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 Serialization 2016-2017 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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You can rely on us - Orion Contract Manufacturing

CONTACT US FOR MORE INFORMATION

Jari Kaunisto Director Sales and Marketing Contract Manufacturing jari.kaunisto@orionpharma.com

  • Tel. +358 50 966 3543

Maria Moukola Business Manager Contract Manufacturing maria.moukola@orionpharma.com

  • Tel. +358 50 966 7162

Visit our web page:

www.orion-cmo.fi

Contact us via email:

cmo@orionpharma.com

Follow us in LinkedIn

Orion Contract Manufacturing