avara corporate capabilities presentation 11-8-16

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Avara Capabilities Presentation Experience At Your Side October 2016

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Page 1: Avara Corporate Capabilities Presentation 11-8-16

Avara Capabilities Presentation

Experience At Your Side

October 2016

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Contents

Experience Avara• Introduction

• Leadership Team

The Avara Promise

Experience The Difference

Avara's Capabilities • Overview

• Primary Manufacturing

• Secondary Manufacturing

• Packaging

Customer Profile

Avara's Locations

• Arecibo, Puerto Rico

• Shannon, Ireland

• Norman, Oklahoma

• Avlon, United Kingdom

• Norwalk, Connecticut (headquarters)

Avara and You

Thank You

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Experience Avara

We are led by a highly experienced management team comprised of industry veterans

Our company mission is to consistently deliver on our commitments

We offer a global network of world-class facilities with proven commercial records

We put value on people to retain long-tenured staff so institutional expertise remains embedded at our facilities

We are flexible to your needs, merging the agility of a nimble provider with the qualities of a large company

Avara Pharmaceutical Services is a CDMO set up specifically to focus on customers and deliver a world-class outsourcing experience.

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Experience Our Team

Tim Tyson – Chairman & CEOOver 35 years leading pharma businesses and contract providers – instrumental in bringing more than 50 medicines to market.

Jim Scandura – Director & COOManaged three major manufacturing network change programs, over 30 site audit and operational improvement efforts, and integration of an R&D center and manufacturing sites.

Keith Lyon – Director & CFOCareer experience with several buyouts, three public offerings, and C-Suite or Treasurer roles including Nestlé, First Chicago Bank, Duracell, and Estée Lauder.

Bill Pasek – Chief Commercial Officer25 years of experience in sales leadership including GSK, Sunovion, and Quintiles

Don Britt – Chief Quality Officer40 years of experience in quality / regulatory, including GSK, Abbott Labs, Bayer, and Sanofi-Aventis

Rick Mark – Chief HR OfficerLed Human Resources in 5 industries, with HR due diligence resulting in $1B in acquisitions

Avara was founded and is run by a team of industry veterans who have been on both sides. We know how to deliver an exceptional CDMO experience to you.

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The Avara Promise

One of the CDMO market’s most experienced leadership teams

Systemic commitment to on-time, in-full delivery at a fair price

World-class facilities, proven commercially to meet the highest quality and reliability standards

Long personnel tenure at all facilities, delivering experience, institutional knowledge and consistency

Flexibility based on intently listening to customers, and the agility to respond quickly

Transparency in communications, and overall integrity that drives trust

We will provide a world class, customer-oriented CDMO experience and deliver on our commitments. The foundation of this mission is based on:

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Experience The Difference

Flexible manufacturing footprint across Europe and North America, comprising a portfolio of commercially-proven facilities

Operational excellence and a compliance-oriented quality program based on Lean Six Sigma methodologies

Regulatory support and delivery covering more than 100 international markets

Commitment to listening to customers’needs and the flexibility to align with them and deliver on our commitments

Optimization through industry best practices including continuous improvement

We offer primary and secondary manufacturing with integrated packaging, supplying drug substance and drug product from world-class facilities

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Capabilities Overview

cGMP development, scale-up and supply of APIs, including hazardous materials

Clinical and commercial-scale supply of solid dose drug product, including high potent capabilities

Integrated packaging & supply chain support

Development support – process optimization, analytical methods, and release / stability testing

GRANULATIONBroad experience with tech transfers, commercialization and product launches

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Primary Manufacturing

Multiple cGMP API facilities / capabilities

Center of Excellence for drug substance

Dedicated small-scale production / Kilo Lab (60 L – 75 L reactors)

Large-scale production (1m3 to 32m3 capacity)

Specialization in hazardous / complex chemistry

Process scale-up and optimization

Multi-product potential

Avara has two sites that develop, scale up and manufacture APIs for some of the market’s leading drugs

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Primary Manufacturing

Centrifuge & Nutsche Filter Isolation

Alkylation

Nitration

Grignards

Hydride Reduction

Hydrogenation

Cryogenic Processing

Milling & Blending of APIs

Avara has two sites that develop, scale up and manufacture APIs for some of the market’s leading drugs

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Secondary Manufacturing

Two global multi-product facilities provide secondary manufacturing services

Clinical and commercial-scale manufacturing and packaging

High containment capabilities for potent products

Broad experience with tech transfers

Global compliance-oriented quality program based on Lean Six Sigma methodologies

Regulatory support across more than 100 countries

Avara manufactures multiple blockbuster drugs, serving some of the world’s leading pharmaceutical companies

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Secondary Manufacturing

Milling

Spray Drying

Granulation (High Shear, Roller Compaction, Fluid Bed)

Blending

Compression

Coating

Tablet Printing

Capsule Filling

Avara manufactures multiple blockbuster drugs, serving some of the world’s leading pharmaceutical companies

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Packaging

Blisters• 100-300 blisters per minute• Form, fill and seal• Automated cartoning and inspection• 150 cartons per minute• Laser printing, automated inspection

Bottles• Capsules and tablets• 75cc and 120cc bottles• High-speed lines, 100-300 bottles

per minute• Slat filling technology• Laser printing & automated inspection

Serialization• To international requirements

Integrated packaging capabilities to optimize costs and increased efficacies.

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Commercial Products

Avara has manufactured APIs and finished dosage forms for multiple blockbusters

Betanis®

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Client Relationships

Avara has served and currently serves some of the world’s leading pharmaceutical companies

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Arecibo, Puerto Rico

ARECIBO, PUERTO RICO

Facility Overview

Acquired from Merck & Co.

Over 35 years of site experience

Continual investment by Avara

Secondary manufacturing and integrated packaging

Manufactures multiple commercial products, including blockbusters

Granulation, coating, blending, encapsulation, compression & drying

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Shannon, Ireland

SHANNON, IRELAND

Facility Overview

Acquired from UCB

Over 40 years of site experience

Primary manufacturing

API scale-up from lab to commercial scale (8,000 L)

Multi-product flexibility

High containment capabilities

cGMP

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Norman, Oklahoma

NORMAN, OKLAHOMA

Facility Overview

Acquired from Astellas Pharma

Over 35 years of site experience

Secondary manufacturing and integrated packaging

Manufactures six commercial products, including blockbusters

Clinical and commercial-scale supply

Milling, spray drying, granulation, blending, compression coating, tablet printing

Development support

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Avlon, United Kingdom

Facility Overview

Acquired from AstraZeneca

Over 45 years of site experience

Worldwide Pharmaceutical Services Center of Excellence

Primary manufacturing

API manufacture for Crestor®

and Seroquel®

High containment capabilities

Separate tech transfer / small-scale facility and large-scale facility

AVLON,UNITED KINGDOM

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Avara and You

Committed to delivering an exceptional customer experience

Company culture to deliver on our commitments

Transparency in all operations and communication

Flexibility to your priorities and the agility to respond quickly

Integrity in everything we do to earn your trust

Avara is committed to being easy to do business with. When you engage with us, you will immediately witness our drive to deliver a world-class customer experience.

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Experience More

We are grateful for your time and the opportunity to make this presentation.

We’d like to listen to your needs to understand how Avara’s approach can exceed your expectations with a world-class outsourcing experience.

Please visit www.avara.com

Thank You