Actavis plc: Salt Lake City Site Overview BioUtah Life Science Summit, Nov. 5, 2014 Michael Kimball Executive Director, Transdermal Development Actavis.

Actavis plc: Salt Lake City Site Overview BioUtah Life Science Summit, Nov. 5, 2014

Michael KimballExecutive Director, Transdermal DevelopmentActavis plcSalt Lake City, Utah

Actavis plc

Global, integrated specialty pharmaceutical company

Markets approximately 1000 branded, generic, OTC medicines in 60+ countries

Therapeutic focus areas: central nervous system, gastroenterology, women’s health, urology, cardiovascular, respiratory and anti-infective

Headquartered in Dublin, Ireland

Administrative headquarters located in Parsippany, NJ

Salt Lake City Facility

Both R&D and commercial manufacturing for high-barrier products: Combination Modified Release Products (Patches), Semi-Solids, Liquids, Oral Thin Films (Gx and Rx)

Key contributor to an industry-leading R&D program as well as commercial sales

Nucleus of a growing local pharma cluster?

Actavis Global Supply Chain

Actavis Salt Lake CityCenter of Excellence for Transdermals, Topical Gels and Ointments

Salt Lake City, Utah, USA

Actavis’ Salt Lake Site History

1985 1993 1995 1997 1999 2003 2009 2012 2013 2014

TheraTech founded by Drs.

Patel, Kim, Higuchi

First NDA filed: Androderm

Ground-Breaking for Plant

Androderm Approved & Launched

Alora NDA Approved

Watson Buys TheraTech

Oxytrol Patch Launched

R&D Building Completed

Watson Acquires Arrow

$44 Million Site Expansion Completed

Watson Acquires Actavis, Adopts

Name

Actavis Buys Warner Chilcott

Actavis Acquires Forest

Bldg. 577

577 Chipeta Way138,400 Square Feet

• Administration• R&D Lab• QC Lab

Bldg. 579

579 Chipeta Way105,000 Square Feet• Warehouse

Bldg. 575

575 Chipeta Way87,700 Square Feet• Manufacturing• Packaging• Administration

Chipeta Way

Colorow

Rd.

Salt Lake City Campus:Research Park at University of Utah

Manufacturing Expansion17,000 Square Feet ( Foot Print )

Key Salt Lake CityManufactured Products

AloraEstradiol Transdermal SystemTherapeutic Indication: Estrogen Replacement Therapy

AndrodermTestosterone Transdermal SystemTherapeutic Indication: Testosterone Replacement Therapy

Cordran TapeFlurandrenolide Tape, USPTherapeutic Indication: Corticosteriod Responsive Dermatoses

FentanylFentanyl Transdermal SystemTherapeutic Indication: Moderate to Severe Chronic Pain

GelniqueOxybutynin Topical GelTherapeutic Indication: Overactive Bladder

LidocaineLidocaine Transdermal SystemTherapeutic Indication: Pain Relief of Post-herpetic Neuralgia

OxytrolOxybutynin Transdermal SystemTherapeutic Indication: Overactive Bladder

CrinoneProgesterone GelTherapeutic Indication: Progesterone Supplement / Replacement

ClonidineClonidine USP Transdermal SystemTherapeutic Indication: High Blood Pressure

Drug Delivery Technologies

Liquid Reservoir System (LRS)- Androderm® (Testosterone) Transdermal System

- Duragesic® (Fentanyl) Transdermal System

Matrix (MTX)- Oxytrol® (Oxybutynin) Transdermal System

Hydrogel- Lidocaine (Lidoderm®) Transdermal System

Topical Gel- Gelnique® (Oxybutynin) Sachet

Syringe Applicator- Crinone® (Progesterone) Gel

Oral Thin Film (Sublingual)- Suboxone® - In development

Tube- Testim® - In development

Metered Dose Pump- Androgel® & Gelnique® – In development

Liquid Fill- Oral pain product - In development

Sterile Fill - Opthalmics – Proposal drafted

Backing Film

Gel Reservoir

Gel Reservoir Seal

Microporous Membrane

Peripheral Adhesive

Peelable Disc

Release Liner

Transferred Adhesive

Peelable Disc

Adhesive

Release Liner

LRS - Liquid Reservoir Systems

Liquid Reservoir Patch

Flexible Backing Film

Release Liner Strips with Overlapped Peel Tab

Matrix Adhesive Layer

MTX - Matrix Systems

Matrix Patch

Heat-SealedArea (Gray)

2.0"2.5"

Tear Notch

Gel Reservoir(White)

Heat-Seal LayerAdhesiveBarrier LayerPlastic LayerPaper Layer

Paper LayerPlastic LayerBarrier LayerAdhesive

Topical Gel Sachet

Hydrogel Patch

Oral Thin Films

Syringe ApplicatorTubes

Notable Growth in Actavis’ SLC Technology

Five years ago, the SLC facility utilized two technologies:

• Matrix transdermal patches• LRS transdermal patches

Today:• Matrix transdermal patches • LRS transdermal patches• Hydrogel patches • Topical gels • Syringe Applicators • Oral Thin Films• Tubes • Metered Dose Pumps

Introduction of hydrogel-based topical patches• Challenging technology originally developed in

Japan• SLC is the first site in the United States to

successfully develop/market this technology (Rx)• State-of-the art equipment; 40x scale-up from R&D• 1 million patches made every 3 days

Shifts of Operation and Capacity – Commercial Plant

• Manufacturing/Packaging/QA Support staffed 24/7

− Two 12-hour shifts running Monday through Thursday

− Two 12-hour shifts running Friday, Saturday and

Sunday

• QC Laboratories staffed 24/7

• Budgeted to produce 140 million systems in 2014

• Forecasted to produce over 250 million systems

by 2016

• Total Plant Capacity – Approx. 500 – 700 million

systems per year depending on the technology of

drug delivery

R&D Overview: Salt Lake City

• R&D Manufacturing Facility

– Operates 51 weeks out of the year

– 12-hour shifts running Mon-Fri

– 11,000 sq. ft. manufacturing space

• Expansion space available

– Produced 146 batches in 2013 (vs. 72 in 2009)

• State-of-the Art Analytical Capabilities

– HPLC, UPLC, GC, GCMS, LCMS, NMR, MALS, CAD

Salt Lake City Headcount

Total ~ 540 Employees

Technical Operations 359R&D 146Shared Services 35

Total 540

Tech Ops71%

R&D22%

Shared Services7%

Salt Lake City Site Highlights

Notable Achievements and Community Outreach:• 2010 & 2012 Plant of the Year• Largest in-house Product Launch in Actavis History: Lidocaine (September, 2013)• Community Outreach: March of Dimes “March for Babies Campaign”

2012 Actavis Employee Chaired the Salt Lake County “March for Babies” 2013 Actavis SLC recognized as one of the top three contributors in the state of Utah. 2013 Top two walkers in the state of Utah were Actavis SLC Employees 2014 SLC Site raised over $37,000 for the March for Babies 2014 One Actavis SLC employee raised over $10,000 for the Babies

2014 2015 2016 2017 2018 -

50,000

100,000

150,000

200,000

250,000

300,000

350,000

SLC Volume Growth (Based on Sales Forecast)Sa

les F

orec

ast i

n 00

0 Eu

s

21

BioUtahPeter KnauerKimball ThompsonKevin JessingWade Hull

Scott Gochnour, Actavis plcJohn Spigiel, Actavis plc

Acknowledgements