Acino Contract Manufacturing OverviewIntroduction to Acino Contract Manufacturing Services

Acino Key Figures

Acino at a Glance

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Headquartered in Zurich, Switzerland, Acino develops, manufactures and commercializes high quality pharmaceuticals for the benefit of patients

Acino takes leadership through commercial excellence in selected emerging markets with own Acino brand

Middle East, Africa, CIS, Russia and LATAM

Swiss manufacturing sites serve a variety of B2B customers

Out-LicensingAcino products sold in European and other markets by a broad range of leading pharmaceutical companies

Contract ManufacturingCustomers’ products are manufactured and packaged by Acino, often with a full-service business model

313 m€Sales in 2017

~1’900Employees globally

+14%Annual growth in 2017

~550Employees in Switzerland

80% : 20%Sales split B2C : B2B

3 Manufacturing sites (CH, EE, UA)

182 YearsOf Swiss company history

100%Privately owned by Avista Capital & Nordic Capital

Contract Manufacturing

Technology we’re proud of

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We have the know-how, technology and infrastructure to support youachieving your needs.

Our in-house engineering team has the experience and know-how tobe able to adapt or bring in technology solutions quickly.

We continue to invest in a range of technologies, capabilities andcompany structures to stay competitive.

We are ready for serialization; not only bringing it in before marketdeadlines, but ensuring we can easily scale to future products.

>50 Years experience in pharm. manuf.

>60Countries being supplied with our products

10multi-national pharma customers

27small-medium sized pharma customers

Quality in all we do

100%Passed audits & HA inspections

17Customer audits in 2016

3 Health Authority audits in 2016

224Quality employees in 2017

Our Quality Mindset is rooted in our Swiss heritage.

We meet and exceed the highest standards for our products, as well as using our own quality culture to continually improve our offer.

Our global Quality strategy that covers all aspects of our business, from the relationships we develop to the products we deliver.

Our Quality Policy greets every visitor and employee in every site entrance in Acino.

Our global CMO presence

Headquartersin Zurich,

Switzerland

Liesberg, Switzerland

Aesch, Dornacherstrasse, Switzerland

Põlva, Estonia

Kiev, Ukraine

Manufacturing

ManufacturingPackaging

ManufacturingPackaging

Packaging, Logistics,Warehouse

AL

AD

AE

AU

Aesch,Pfeffingerring, Switzerland

Packaging, Logistics,Warehouse

AP

CH EE UA6

Our OSD Center of Excellence

Since many decades Acino has been manufacturingpharmaceuticals. With many successful in-housedevelopments, we have gained in-depth knowledge inbringing products from development to commercializationand expertise in solid dosage forms by constantly optimizingand improving our processes.

~130Employees

~55Employees in production

3’400 m2Production area

10’500 m2Total site area

33 kmDistance to Basel

3 bnBulk unit capacity

Overview Health Authority Audits - Liesberg, Switzerland

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Regulatory Authority Date of inspection Country / Region

Regional Medicines Inspectorate of Northwestern Switzerland on behalf of Swissmedic (Swissmedic)

February 2017 Switzerland

Swissmedic March 2014 Switzerland

Swissmedic December 2011 Switzerland

Executive Board of the Health Ministers’ Council January 2011 Gulf Cooperation Council

• The Liesberg facility is routinely inspected by both its international clients and its local Health Authority – Swissmedic

• The facility is approved for all European countries, Canada, New Zealand and Australia through mutual recognition and ships to multiple destinations such as, Europe, Asia, MEA, South America etc.

• The facility is currently under accreditation process by the Japanese authority (PMDA)

• Russian audit (GISK) expected during 2019

Our Packaging and Logistic Center in Estonia

Our Estonian packaging site in Põlva offers our customerspackaging services for OSDs at the highest flexibility in termsof order volumes, costs and delivery performance, whileapplying highest Acino quality standards. From large scaledown to small manual packaging order volumes, ourEstonian team is capable to transform their flexibility to acustomer’s benefit.

~62Employees

42%Employees with higher education

1176 m2Packaging site area

5100 m2Total site area with technical area and warehouse

228 kmDistance Tallinn to Polva

15 mioPacks packaging capacity

Health authority inspections, customer &internal audits, Põlva, Estonia

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Competent authority/ corporate audits Date of inspection Country / Region

Veterinary and Food Board December 2013 Estonia

Veterinary and Food Board November 2014 Estonia

State Agency of Medicines January 2015 Estonia

Veterinary and Food Board November 2015 Estonia

Veterinary and Food Board September 2016 Estonia

State Agency of Medicines February 2018 Estonia

Veterinary and Food Board March 2018 Estonia

Customer audit Date of inspection Comments

MNC Company 1 – external audit: initial qualification September 2017 Acceptable

Acino (AL) – initial assessment audit April 2018 Acceptable

MNC Company 2 – qualification audit June 2018 Acceptable

Acino CMO Offering - Overview

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Granulation/Pelletization

• Aqueous, organic & dry granulation

• Fluid-bed & high shear granulation

• Direct compression• Extrusion • Spheronization• Direct pelletization in

fluid-bed process• Coating of pellets• Fluid-bed and tray

drying• Sieving

Oral Solid Dosage Bulk

• Modified-release Tablets (MUPS & Matrix Tablets)

• Film coated- or Dispersible- Tablets

• Printed Tablets• Modified-release

Capsules (MUPS)• Capsules• Micro-tablets in

Capsules• Narcotics

Primary Packaging

• PVC/PVDC• Alu/PVC• Alu/Alu• Narcotics packaging

(AP & AE)• Highly actives

packaging• Bottles (Glass, plastic,

aluminum) with different caps (push-on, screw, snap safe, desiccant capsules)

Secondary Packaging

• Standard secondary packaging (for packs & bottles)

• PIL-packages• Artwork management• Serialization &

aggregation starting Nov 2018

• Warehousing & logistics

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AL AL

Our flexibility – your choice

Due to our flexibility, our customer can choose the right set-up for their supply chain. Our team will assist our customers to choose the perfect solution.

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AL AE

Our flexibility – your choice

Due to our flexibility, our customer can choose the right set-up for their supply chain. Our team will assist our customers to choose the perfect solution.

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AP

Our flexibility – your choice

Due to our flexibility, our customer can choose the right set-up for their supply chain. Our team will assist our customers to choose the perfect solution.

• Pelletization:• Granulation / Extrusion / Spheronization• Direct pelletization in Fluid Bed Process

• Wet granulation:• Fluid Bed and High Shear Granulation• Aqueous & organic granulation: Isopropanol & Ethanol

• Dry granulation / Roller compaction

• Our offerings:• Pellets• Granulates

10fluidized bed granulators in CH

350 tof pellets & granulate produced in 2016

Granulation

available at

AL AUAP AE

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• Focus on hard-to-make generics & niche-technologies

• Suspension layering & modified-release dosage forms

• Strong expertise in narcotics production

• Our offerings:• Modified-release Tablets (MUPS & Matrix Tablets)• Film- or Dispersible- Tablets• Printed Tablets• Modified-release Capsules (MUPS)• Capsules• Micro-tablets in Capsules

available at

AL AE AU

Bulk Production

AP

2 bnbulk units free capacity in CH

up to 900 ktablets / hr

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• Small scale to large scale batch sizes (50’000 – 4’000’000 units)

• Clinical trial material and Small scale commercial manufacturing

• Support in late stage development & product launch

• Broad and current tech transfer expertise, process optimization

• Our offerings:• Granulation / pelletization• Encapsulation• Compression• Coating

300 m2floor space

2 - 2’000 kgbatch size

available at

AL AUAP

Flexible scale

AE

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• Price competitive:• High speed lines in AP for larger batch sizes• Low-cost packaging in AE for small batch sizes

• Transport to AE under GDP conditions and in full responsibility of Acino

• Our offerings:• PVC/PVDC• Alu/PVC• Alu/Alu• Narcotics packaging (AP & AE)• Highly actives packaging• Bottles - glass, plastic, aluminum - with different caps: push-on, screw, snap safe, desiccant

capsules

133 mioblisters packed in 2016

5’250 kmof aluminium foil used in 2016

available at

AL AE AUAP

Primary Packaging

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• Batch release according to customer wishes• CH batch release in AP• EU batch release in AE

• Transport to AP under GDP conditions and in full responsibility of Acino

• Serialization/UI & tamper evidence • Implemented and running in AP; standard Acino-wide implementation Nov & Dec 2018 • Tracelink data sharing

• Our offerings:• Standard secondary packaging (for packs & bottles)• PIL-packages• Artwork management• Serialization / aggregation

40 miopacks shipped in 2016

~1'000 kmhigh tower of all packs shipped in 2016

available at

AL AE AUAP

Secondary Packaging

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• Acino can be your full service CMO:

• Worldwide API, raw material and FDF sourcing, including supplier qualification

• Warehousing & distribution services

• Regulatory support

• Process optimization

• Additional QC Services for customers

2’303global registrations

300qualified suppliers in 2017

available at

AL AE AUAP

Additional Services

Liesberg & Aesch Quality ControlOur brand new Quality Control laboratories meet and exceedthe highest quality standards and requirements.We have know-how, technology and facilities to support youachieving your projects goals. Continuously investment in ourequipment with the latest technologies constantly increasesour capabilities.

1200 m2QC area

~50Employees in QC

29HPLC Instruments

6UPLC Instruments

2’837Samples analysedin 2017

25, 30 & 45° CStability chambers

Environment, health & safety

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Environment, Health and Safety (EHS) is an integral part ofgeneral management at Acino.

The role of EHS is to provide the required tools to complywith all regulations regarding occupational safety, hygieneand medicine, environment, legal compliance and corporatesocial responsibility.EHS ensures the appropriate application of these tools forsafe workplaces and, at the same time, respect of theenvironment. EHS supports Acino in taking all responsibilitiesof an employer to protect employee`s integrity andenvironmental resources for a sustainable future.

- 35%Less accidents within one year (2018)

OEL 1 - 3Level bulk manufacturing

- 30%Less rate of illness within one year (2018)

4’192 hInternal EHS training (2018)

EHS Politics

EHS Standard

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EHS System & Culture

Your partner from wish to productWhen you engage Acino, you are getting a true partner.

We think this starts with transparency and right expectations– before we go in to business together we make sure weunderstand your means in full. Our team will then proposethe best options.

We know how situations can change within a minute, so wecommit to highest flexibility in our offerings, services and inour every-day work to meet our customer’s demands &expectations

100%clarity on contact persons

100%commitment

1dedicated CMO Account Manager

up to 4status calls per month

Project Management that goes beyond

14transfer projects in 2018

~ 6 – 8 mduration of a packaging project

max. 1month from RFQ to offer

~ 12 – 18 mduration of a bulk project to finalization of validation

Our project management goes beyond the technicalrealization of your project: By assuring fairness andtransparency in our project proposal, we keep an eyeon your budget and timelines.

The key to a successful project is a good planning – westrive for close collaborations and open communicationwith our customers directly from the start to make itwork right from the beginning.

With our long-term experience in manufacturing of oraldelivery forms, knowledge of your target markets &regulatory excellence, we can advise our customers inmany aspects to make your project a success.

Acino Transfer Projects

Project Preparation

Technical Feasibility Trials

Preparation Process Validation

Process validation

Stability Studies

Documentation

Registration Continuous Supply

Documentation exchange

Transfer Plan

Preparation Material No.

Ordering/Delivery of API/Excipients

Ordering of Tooling

Small Scale Technical Trials

Testing of Analytical Methods

Analytical Method Validation

Preparation Validation Plan

Signature round Documents

Ordering/ Delivery of API/Excipients

Production of Validation Batches

Analytics of Validation Batches

Packaging of Stability Samples

Stability Studies according ICH Guidelines

Validation Report

Stability Report

Submission to relevant authorities

Approval of authorities

9 - 15 months 3 - 12 months

Swiss time >99%OTIF target

1dedicated CMO Global Supply Chain Manager

99%batch release on time

370GDP European road transports with partners

As a Swiss company, we make a commitment to thedeadlines and we agree with our clients on OTIF KPIs.

In contract manufacturing there are times when weface challenges and it’s times like this that you need areliable partner.

If deadlines are ever at risk we will inform you as soonas we know and give you a clear overview of thesituation.

When we know, you know

Why work with us?

Swiss Quality Flexibility Technology & Know-How

Stable Supply Chain

Open, transparent & pro-active communication

Our Liesberg Team

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Our Estonia Team

Your contacts within Acino

Felix FaupelHead of Contract Manufacturingfelix.faupel@acino.swiss

Yuliyana ManolovaBusiness Development Contract Manufacturingyuliyana.manolova@acino.swiss

linkedin.com/company/255145/ acino.swiss/contractmanufacturing/ facebook.com/acino.swiss

Our Quality Our TechnologyOur FlexibilityYOUR BENEFITYOUR CHOICE

Thank you for your attention!