Logistics Ireland 2010

Rx for Global Supply Chain

Paul Condon

Genzyme Ireland Ltd

Presentation Overview

• Genzyme Corporation

• Genzyme in Ireland

• Corporate Operations Strategy

• Waterford Operations Mandate

• Supply Chain Strategy

Our Global Corporation

• >12,000 employees worldwide

• Helping patients in 100 countries

• 17 manufacturing sites

• 20 major marketed products

• 2009 revenue of $4.5 billion

• 85 locations in >40 countries

• Henri Termeer: Chairman, CEO

Our Revenue Growth

$0

$500

$1,000

$1,500

$2,000

$2,500

$3,000

$3,500

$4,000

$4,500

$5,000

'95 '96 '97 '98 '99 '00 '01 '02 '03 '04 '05 '06 '07 '08 '09 '10

$M

(1H)

Our Focus

We develop

breakthrough therapies

to meet unmet medical needs

We are committed to

making a significant improvement

in patients lives

We are patient focused

Our Major Marketed Products and Services

Cerezyme®

Fabrazyme®

Aldurazyme®

Myozyme®

LumizymeTM

Personalized

Genetic Health

Renagel®

Renvela®

Hectorol®

Thyrogen®

Renal and

Endocrinology

Mozobil®

Clolar®

Campath®

Fludara®

Leukine®

Thymoglobulin®

Hematology and

Oncology

Genetics

Diagnostics

Other

Synvisc®

Synvisc-OneTM

Carticel®

MACI®

SepraTM Products

Biosurgery

Personalized Genetic Health

• LSDs (Lysosomal Storage Disorders)– Ultra-rare diseases (<10,000 patients worldwide)

– Progressive, debilitating diseases

– Missing enzyme causes health problems

• LSDs & Genzyme– Produce genetically engineered biologics to replace the

enzyme

– Introduced the first product approved to treat an LSD (1991)

– Marketed Products

• Cerezyme® (imiglucerase for injection) for Type 1 Gaucher disease

• Fabrazyme® (agalsidase beta) for Fabry disease

• Aldurazyme® (laronidase) for MPS-I

• Myozyme® (alglucosidase alfa) for Pompe disease

• LumizymeTM (alglucosidase alfa) for late-onset Pompe disease

Fabrazyme – Fabry disease

Renvela – chronic kidney disease not on dialysis

Mipomersen – hoFH and severe hypercholesterolemia

Prochymal – steroid refractory graft vs. host disease

Alemtuzumab – multiple sclerosis

Ataluren – Cystic Fibrosis

Prochymal – Crohn's disease

Eliglustat tartrate oral therapy – Gaucher disease

TSH – nontoxic multinodular goiter

Clolar – previously untreated adult AML

Thymoglobulin – myelodysplastic syndromes

Acid Sphingomyelinase – Niemann-Pick Type B

GC 1008 – kidney sclerosis

Gene therapy – Parkinson's disease

Mozobil – tumor chemosensitization

0 1 2 3 4 5

Late Stage Product Pipeline

Pre-Clinical Phase 1 Phase 2 Phase 3Post

Marketing

Genzyme – a world leader

• Consistently named a top employer by Science

• Rated among the most generous in-kind givers by

BusinessWeek

• Consistently named to the Dow Jones

Sustainability World Index

• Genzyme Center among the most

environmentally responsible U.S. buildings

• Genzyme was named one of the most ethical

companies by Ethisphere magazine

• Awarded the National Medal of Technology

Genzyme Ireland Operations

Pharmaceutical Investment in Ireland

• Number 1 location in Europe for Life Sciences projects

• 8 of the top 10 Pharma companies in Ireland (13/20)

• €34bn in Pharmaceutical Exports

• 44,000 employed in Life Sciences

• Excellent regulatory record

• 32 FDA approved Pharmaceutical Plants

• €1bn+ Corporate Tax

World’s Leading Companies in Ireland

37 acres on the edge of Waterford city.

Genzyme Waterford - Brief History

• Purchased Luxottica (Rayban) facility on 15 acres in 2001– Additional 16 acres purchased from IDA.

• Phase 1 (2002): Rayban facility converted to OD I tabletting. – Renagel & Renvela (Cholestagel to follow)

• Development Facility (2003)

• Phase 2 (2006): Sterile Fill/Finish added to expanded site.– Thymoglobulin, Myozyme, Cerezyme

• Phase 3 (2008): OD II facility – Renagel & Renvela

• Phase 4 (2008): Fill/Finish expansion project commenced

• €450m capital investment on site to date

Number of People

• December 2002

– 83 Team Members

• December 2003

– 140 Team Members

• December 2004

– 197 Team Members

• December 2005

– 268 Team Members

• December 2006

– 328 Team Members

• December 2007

– 401 Team Members

• December 2008

– 459 Team Members

• December 2009

- 465 Team Members

• Irish Medicines Board – November 2007

– Routine GMP Inspection of OD & FF

• Health Canada – November 2007

– PAI for Fill Finish products

• US Food & Drug Administration, CBER– January 2008

– Thymoglobulin Routine Inspection

• Gulf Central Committee– February 2008

– Fill Finish & Oral Dose Audit

• ANVISA Brazil – April 2008

– Fill Finish & Oral Dose Audit

• Ukraine Dept of Health – June 2008

– Fill Finish & Oral Dose Inspection

• Japan PMDA – Oct 2008

– PAI & Fill Finish Inspection

• FDA – Nov 2008

– Oral Dose Inspection

Genzyme Ireland – Regulatory Inspection History

• Irish Medicines Board – October 2002

– Initial Audit of Tablet Operations

• US Food & Drug Administration, CDER – June 2003

– PAI for Renagel Supply to US

• Gulf Central Committee – September 2003

– Supply of Renagel to GCC Countries

• Irish Medicines Board – September 2004

– IMP Audit (Clinical Supply) – solid and liquid dosage forms

• ANVISA Brazil – October 2004

– Supply Renagel to Brazil

• Irish Medicines Board – June 2005

– Testing & Release of Biological Products/Initial FF audit

• Irish Medicines Board – October 2005

– Routine GMP Inspection of Oral Dose area

• Irish Medicines Board – January 2006

– Approval of Fill Finish Operations

• US Food & Drug Administration, CBER – April 2006

– PAS for Thymoglobulin Supply to US

• US Food & Drug Administration, CBER– January 2008

– Thymoglobulin Routine Inspection

• Gulf Central Committee– February 2008

– Fill Finish & Oral Dose Audit

• ANVISA Brazil – April 2008

– Fill Finish & Oral Dose Audit

• Ukraine Dept of Health – June 2008

– Fill Finish & Oral Dose Inspection

• Japan PMDA – Oct 2008

– Fill Finish Inspection

• US Food & Drug Administration, CDER– Nov 2008

– Oral Dose Routine Inspection

• Iranian MoH– Feb 2009

– Thymoglobulin PAI Inspection

• Mexican MoH– May 2009

– Thymoglobulin PAI Inspection

• ANMAT Argentinian MoH– October 2009

– Fill Finish PAI Inspection

• US Food & Drug Administration, CBER– October 2009

– Myozyme PAI Inspection

• Irish Medicines Board – November 2009

– Routine GMP Inspection of OD & FF

Genzyme Ireland – Regulatory Inspection History (cont)

18

Supply Chain Context

“In today’s business world, efficient supply chain management, that

is aligned with business strategy, is necessary to remain competitive

and profitable.

Competition is no longer company versus company, but supply chain

versus supply chain.”

Prof. Carlos Cordon, IMD, Switzerland

Seeking dynamic alignment means treating your supply chain as a

living being not a mechanical beast.

John Gattorna

Vision: Genzyme Manufacturing & Corporate Operations

• A core strategic asset known for its operational

excellence across a broad range of technology

platforms and an unfailing ability to deliver a

quality product to patients in need.

World Class Manufacturing

Corporate Operations Goals & Priorities for 2010

1.Quality Systems

2.Product Supply

3.Technology Leadership

4.Massachusetts Biologics

5.Behavioral Change

Product Supply

• We recognize the importance of ensuring product availability and supply chain predictability, visibility, and flexibility

• Until our product arrives as scheduled to serve the patient in need, we cannot claim success for any aspect of our operation – Ultimate measure of operational excellence

To achieve the Waterford organisation’s potential by

developing a sustainable, competitive Manufacturing

Environment supplying Genzyme’s growing patient

product needs around the world.

Waterford Site Vision

Key Elements to our Strategic Plan

2008 2012

Patient Supply

Additional

Finishing Platform

Additional Volume and

Products

Key Supply Sites & ~ 25 CMOs

Haverhill

GeelLyon

MA

Supply Chain in Biotech Manufacturing

• Cells are grown in bio-reactors and product is

purified.

• Bulk is filled into vials

• Drug product is packaged to meet country and

language specific requirements

• All this happens in a time and temperature

sensitive manner.

What are our supply chain challenges today?

Manage and introduce new products.

Increase visibility, planning, forecasting &

execution robustness

Manage global complexities

Deliver product safely around the world

Control associated risks

Ensure compliance to regulations and local duties

Deliver cost savings

What are our supply chain challenges today?

• We need to move from a supply centric focus (push

=output and optimisation) to a demand driven network

(pull)

• This involves a change of mindset and a calibration of

what is driving the business.

• Our lean thinking is helping us move in this direction.

• Need space? - empty the warehouse we have, don’t

build another one!

StrategicStrategic

Sourcing

Product

Governance

TacticalProject &

Resource

Planning

Supply

Planning

Production

Planning

Warehouse

Planning

Transport

Planning

Demand

Planning

Service

Planning

Execution PlanningPurchasing/

Receiving

Manuf’ing

Execution

Warehouse

Operations

Transportn.

Execution

Order

Promising

Manag’t

Support &

Reverse

Logistics

Greater Collaborative Processes

Strategic Source Make Strategic Move Sell Strategic

Where are we trying to get to

Global

Distribution

Logistics Ireland 2010

Thank You

Paul Condon

Genzyme Ireland Ltd