CM presentation 2018 Orion today year 2017 in figures (adjusted) S - - PowerPoint PPT Presentation

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CM presentation 2018 Orion today year 2017 in figures (adjusted) S - - PowerPoint PPT Presentation

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CM presentation 2018 Orion today year 2017 in figures (adjusted) S ales by business Net sales 1,034 MEUR Operating profit 284 MEUR 5% 4% 7% 34% Personnell ~ 3 200 R&D investments 99 MEUR 50% 6 production sites in Finland Own

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CM presentation 2018

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Orion today —year 2017 in figures (adjusted)

Net sales 1,034 MEUR Operating profit 284 MEUR Personnell ~ 3 200 R&D investments 99 MEUR 6 production sites in Finland Own sales unit in 26 European countries

34% 50% 7% 5% 4% S ales by business

On 21 April 2018, Orion signed an agreement on t he sale of all shares in Orion Diagnost ica Oy (i.e. t he Orion Diagnost ica business division). Following t he t ransact ion, Orion Diagnost ica business is report ed as discont inued operat ion. The f igures f or 2017 are adj ust ed, and do not include Orion Diagnost ica. You can rely on us - Orion Contract Manufacturing

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Our businesses

Contract Manufacturing Manufacturing and packaging services for ot her pharmaceutical companies Animal Health Medicine and well-being product s for animals Fermion Act ive pharmaceut ical ingredients (APIs) Proprietary Products In-house developed drugs and

  • t her drugs wit h valid product

prot ect ion Specialty Products Generic prescript ion drugs, OTC and non-medicinal products, biosimilars

You can rely on us - Orion Contract Manufacturing

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You can rely on us - Orion Contract Manufacturing

Orion has operations in 27 countries

Finland

  • HQ
  • Research & development
  • S

ix production sites

  • S

ales unit

  • S

upport functions UK

  • S

ales unit

  • Research & development

Europe

  • S

ales unit in 26 countries India

  • S

upport functions ROW

  • Global partner network

for sales

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You can rely on us - Orion Contract Manufacturing

Orion Manufacturing Operations in Finland

Espoo Plant | ~730 S C and QM employees Dosage forms

 Liquid small-volume parent erals

(vials & ampoules)

 Tablet s & capsules  Inhalat ions

Dosage forms

 Non-st erile liquids, suspensions  Nasal & t opical sprays, drops  Rect al enemas

Kuopio Plant | ~50 S C and QM employees Dosage forms

 Hormone gels & solut ions  Tablet s & capsules  Pot ent & cyt ot oxic t ablet s & capsules  Creams & oint ment s

Turku Plant | ~500 S C and QM employees S alo Plant | ~110 S C and QM employees

 Cent ralized warehouse  Tablet packaging  S

erializat ion Hanko Fermion plant | ~160 employees

 API synt hesis development & product ion

Oulu Fermion plant | ~100 employees

 API synt hesis development & product ion Oulu Kuopio Espoo Turku Salo Hanko

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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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You can rely on us - Orion Contract Manufacturing

If you are looking for a partner who...

Helps

you t o get your product from development t o t he market

WE OFFER

  • Upscaling product t o commercial st age
  • Wide expert ise t hroughout t he whole value

chain

  • Diverse product ion and process capabilit y

as your needs grow

  • Tailor-made complex solut ions

Delivers

wit h high reliabilit y t hroughout product life cycle

WE OFFER

  • Est ablished and highly developed processes

and t echnologies

  • Approvals of global regulat ory bodies and

long t rack record of inspect ions

  • On-t ime delivery reliabilit y
  • S

ust ainabilit y, CS R and EHS pract ices well in place

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You can rely on us - Orion Contract Manufacturing

You can rely on us.

99,5 %

On-time delivery performance in 2017

FDA, EMA, JP , ANVIS A, TGA, Korean FDA, Russia etc.

Compliance

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SLIDE 9

Prepare while others are

daydreaming.

Finnish airport s run t hroughout year despit e t he hard weat her condit ions in wint er. That const ant performance is not a mat t er of luck, it is a mat t er of high st andards and good preparat ion.

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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You can rely on us - Orion Contract Manufacturing

Secure your supply chain

Finland is like this bedrock

  • No hurricanes, floods or

earthquakes

  • S

table 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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You can rely on us - Orion Contract Manufacturing

Our latest GMP inspections and audits

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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

  • S
  • lutions
  • Gels
  • Creams

BATCH SIZES

  • 120-2000 Liters

EQUIPMENT

  • Becomix
  • Krieger
  • Fryma
  • Alu/ Laminate S

achets

  • Pump Bottles
  • S

prays

  • 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
  • S

uitable 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 S

terilization

  • OEL-4/ 5
  • Inj ectable
  • S
  • lutions
  • 20-580 Liters
  • Bosch
  • Bausch & S

tröbel

  • 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
  • S
  • lutions
  • 80/ 300 -1000 kg
  • Fryma
  • Krieger
  • Nordenmatic
  • Groninger
  • King
  • Alu/ Plastic/ Polyfoil Tubes Plastic Pump

Bottles

  • Oral S

yringes

  • Rectal Tubes
  • Nasal & Topical S

prays

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 S

pray Bottles

  • 80-6000 kg
  • S
  • lutions
  • Drops
  • S

uspensions

  • Nasal & Topical S

prays

  • Mixing
  • Homogenisation
  • Filtering
  • Isolators

(Telstar)

PROCESSING DOSAGE FORMS BATCH SIZES EQUIPMENT PACKAGING

  • Bausch & S

tröbel

  • 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
  • S

quare and round bottles

  • 100-1700

Kg

  • Tablets filmcoated/

uncoated/ modified release

  • Capsules, hard gelatin
  • High shear & fluid bed

granulation, FB drying

  • Extrusion and 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 j ars
  • Glass j ars
  • Blister packages
  • Tailor-made

EQUIPMENT

  • Uhlmann
  • S

ystech software

  • TraceLink repository
  • Aggregation
  • Tamper evidence
  • S

emi-manual for special packages

  • Experience since 2015

FACILITY AND PROCESS

  • S

ite 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
  • S

erialization 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
  • S

chedules I-V

  • Fast and easy licensing procedures
  • S

ecure 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

SERVICES

Rout e scout ing, process and analyt ical development and opt imizat ion Commercial manufact uring Part icle engineering and impurit y cont rol

APIS

CDMO for st andard and high pot ency APIs bot h cyt ot oxic and non-cyt otoxic Complex int ermediat es 25 generic APIs for t he global market

REGULATORY AND COMPLIANCE

Approved by FDA since 1979 High qualit y, EHS and sust ainabilit y st andards

EQUIPMENT

Highly aut omat ed facilit ies React or sizes from 10-30 l (R&D) t o 60 –6300 l, t ot al volume

  • f react ors 320 m3

Hast elloy, st ainless st eel, glass-lined Glove boxes for HAPI handling Buss loop of 500 l for hydrogenat ions

CONTACT DETAILS

Teemu Korhonen, Business Development Manager teemu.korhonen@

  • rion.fi

Japan: Jyrki Lämsä, Manager, Marketing and Sales j yrki.lamsa@

  • rion.fi
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You can rely on us - Orion Contract Manufacturing

Packaging and serialization – We are prepared!

2010 2012 2011 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 S erialization and aggregation 2010-2012 S erialization and aggregation started in 2011, all medicines in 2016 S erialization- aggregation for special products 2011-2014 S erialization + aggregation of all exported medicines 2014 S erialization in 2015 and aggregation at latest 2017 S erialization 2016-2017 S erialization in 2017 and aggregation at latest 2023 S erialization 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@orion.fi

  • Tel. +358 50 966 3543

Maria Moukola Business Manager Contract Manufacturing maria.moukola@orion.fi

  • Tel. +358 50 966 7162

Visit our web page:

www.orion-cmo.fi

Contact us via email:

cmo@

  • rion.fi

Follow us on LinkedIn

www.linkedin.com/ company/

  • rion-contract-manufacturing