This document provides an overview of Wyeth's business, including its diversification across scientific platforms, business platforms, and therapeutic approaches. It discusses Wyeth's core biotech/vaccine franchises that have high growth potential, such as Enbrel and Prevnar. The document also summarizes Wyeth's investments in biomanufacturing infrastructure and its leadership in biotech manufacturing and process development. Wyeth's standardized technology platforms are highlighted as helping to improve existing products and drive efficiencies.
2. Forward-Looking Statement
The statements in this presentation that are not historical facts are forward-
looking statements based on current expectations of future events and are
subject to risks and uncertainties that could cause actual results to differ
materially from those expressed or implied by such statements. These risks
and uncertainties include risks associated with the inherent uncertainty of the
timing and success of product research, development and commercialization
(including with respect to the NDA filings for Wyeth’s pipeline products
referenced in this presentation), drug pricing and payment for Wyeth’s
products by government and third-party payers, manufacturing, data
generated on the safety and efficacy of Wyeth’s products, the impact of
competitive or generic products, trade buying patterns, global business
operations, product liability and other types of litigation, the impact of
legislation and regulatory compliance, intellectual property rights, strategic
relationships with third parties, environmental liabilities, and other risks and
uncertainties, including those detailed from time to time in Wyeth’s periodic
reports filed with the Securities and Exchange Commission, including Wyeth’s
current reports on Form 8-K, quarterly reports on Form 10-Q and annual
reports on Form 10-K, particularly the discussion in Wyeth’s annual report on
Form 10-K under the caption quot;Item 1A, Risk Factors.quot; Wyeth assumes no
obligation to publicly update any forward-looking statements, whether as a
result of new information, future developments or otherwise.
4. Wyeth’s Diversification … A Key Asset
Diverse Scientific Platforms
n
100% 5%
Pharmaceuticals, Biotechnology, 12%
Vaccines 80% 7%
60% Non-
% of Revenue
Diverse Business Platforms
n
Traditional
60% 36%
Biotech, Vaccines, Nutritionals, Pharma
Consumer Healthcare, Animal
Healthcare = 60% of Revenue in 40%
2008
20%
Growing to 75% by 2012 40%
Diverse Therapeutic
n
0%
Approaches
YTD 2008
Treatment vs. Disease Prevention
Preventative Therapies
- Human and Animal Vaccines, Infant
Formula, Vitamins, Supplements Pharma Biotech/Vaccines
Nutritionals Consumer
Animal Health
5. Core Biotech/Vaccine Franchises with High
Growth Potential
®
~$6 Billion Global Sales in 2008 31 National Immunization
n n
Programs in Place … on the
#1 Worldwide Biotech Brand
n
Market in 89 Countries
$10 Billion RA/Psoriasis
n
Prevnar 13 Filing for Infants 2009;
n
Biological Market Expansion by
For Adults 2010
2012
Manufacturing Capacity Strong
n
Maintain #1 Position in Category
n
and Growing
Due to Established Safety and
60 Million Doses in 2008
Efficacy Profile
Future Manufacturing Capacity growing to
120 Million Doses
Wyeth - A Leading Biotech Company Globally
Biotech/Vaccine Revenue YTD08 = $6.3 Billion, +20%
7. Traditional Pharma vs. Biotech
Drugs/Vaccines
Biotech Drugs &
Traditional Pharma New Generation
Vaccines
Small Chemical
Size and Complexity 100 to 1000X Larger
Molecules
Manufactured By Chemistry By Living Cells
Chemical Conditions All Steps Support
Sterility of Process
Often Kill Bacteria Bacterial Growth
Usually Tablets Injected or Other
Delivery Mechanism
or Capsules Special Delivery
Maturity of Industry >100 Years ~25 Years
Wyeth Has Been A Leader in
Biotech Manufacturing Since 1983
8. Wyeth Biotech Network
Algete Andover Grange Castle Pearl River Sanford Havant ESN
Spain MA Ireland NY NC UK 3rd Parties
We Have Invested Over $3.5 Billion in Network Infrastructure
n
Between 2000 and 2007 in Support of Product Launch and Growth
In Parallel, We Have Focused on Process Development Working on
n
the Premise That “Biology Will Trump Stainless Steel”
With These Improvements, the Existing Infrastructure Can Sustain
n
the Continued Growth
9. Biotech Process Development
Over 25 Years of Biotech
n
Development Experience
>500 R&D Scientists
30 Different Protein Products
n
Brought Into the Clinic
Drug Substance and Drug Product
n
Development Facilities
Research Labs – 140,000 Sq Ft
Pilot Scale Laboratories in the U.S.
and Ireland
Clinical Manufacturing Facilities – in
MA and NC
10. Cell Line Development
Pre-adapted CHO Host
n
Industrialized and Automated Cell
n
Line Development and Construction
Proprietary Fermentation
n
Technology Increases Outputs
From:
0.5 – 1 g/l – 2001
1 – 3 g/l – 2002
3 – 5 g/l – 2004
10 g/l – 2007
“[in May this year] Wyeth recently created a cell culture system that can
generate 9 grams of protein per liter of culture. Just four years ago, the
standard was 1 gram per liter.” Nature Biotechnology, September 2006
11. Bioreactor and Purification
Process Development
Bioreactor Technology
n
Proprietary, Defined Medium (Animal Protein-free)
Capable of Supporting Highest-density Cultures
Purification Technology
n
Proprietary 2-column MAb Purification Process
Seamless Technical Transfer of Process
n
From Lab Bench to Manufacturing
12. Clinical Production Suites
38,000 sq ft cGMP Multi-
n
product Manufacturing
Equipment/cGMP Systems
n
to Manufacture Two
Products Simultaneously
Cell Culture Bioreactor Hall
n
1 X 6000 L
2 X 2500 L
1 X 500 L
Purification “Suites” Match Bioreactor Capacity
n
Support up to Ten Campaigns Per Year for Both Clinical
n
and Future Commercial Products
13. Industry-Leading Platform Technology
Upstream and Downstream Standard Process Platform Established
n
All Cell Lines Derived From Same Host
All Proteins Produced From the Identical Process Flow
Using the Same Raw Materials, Filters, Buffers, Resins
35% Reduction in Gene to IND Timeline – Product Changeover in Days
n
Single Facility Configuration Can Manufacture All Pipeline and
n
Commercial Products
Wyeth Received the 2008 ACS Industrial Biotechnology Award Given by
n
the Biotechnology Division of the American Chemical Society Honoring
Distinguished Industrial Accomplishments in Biotechnology
Awarded to Wyeth: “in Recognition of Their Achievements in
n
Implementing Industry-leading Platform Technology”
14. Biology Trumps Stainless Steel
Our Investments Are in Process
n
Standardization and
Upstream/downstream Process
Efficiencies and Yields
We Have Implemented the
n
Platform For All Our Pipeline
Products
We Have Established a
n
Proprietary Portfolio of Process
Technologies
We Have Utilized Our Technology
n
Advances in Improving Our
Existing Commercial Products
15. Biology Trumps Stainless Steel:
Commercial Examples
Product New Yields Approval Date
Feb 2008 - EMEA
Enbrel 150%
Feb 2008 - US
Xyntha 200%
Nov 2007 – EMEA
BMP-2 >200%
March 2008 - US
Meets Projected Upside Demand Without Additional
n
Capital Investment
Increases Capacity for Pipeline Products
n
Improves Plant and Product Cost Structure
n
16. ®
Have Developed Process for Prevnar 13v
n
Produced 13v Clinical Trial Material; Phase 3 Trials Have Been
n
Successfully Completed
Invested in Staff and Equipment in Five Facilities in Support of
n
Launch
In 2008, We Manufactured Launch Supply of 13v From All
n
Facilities
We Have Completed 1200 Technical Documents in Support of Our
n
Filing for Infants … Planned by Early 2009
We Have Identified Process Improvements to Allow Us to
n
Ultimately Manufacture up to 120 MM Doses of 13v From Our
Existing Facilities
17. Standardized Technology Platforms for
Traditional Pharma Products
Minimize Capital Investment Through Utilization of One
n
Multi-product Launch Module vs. Building Multiple
Product-dedicated Modules
Improve Existing Large Volume Asset Utilization by
n
Leveraging Existing Infrastructure
Customizing API to Drive Standard Formulations
n
Improve Our Flexibility to Expand/Contract Capacity in
n
Alignment With Product Life Cycle
Align With the Proven Value Demonstrated in Biotech
n
Standardization
18. Standard Platforms Selected Based on Long Term
Manufacturing Ease and Network Fit
H
Tablet:
Tablet:
Wet
Direct
granulation
compression
Modify Excipients or
Network API Properties
(Co-Labs)
Fit Capsule:
Liquid filled
Modify or Outsource Special Formulation Requirements
L H
Manufacturing Ease/Cost Advantage
19. Wyeth: Positioning Itself for Future Growth
Diversified by Business
n
Prescription, Consumer, Animal Health
Primary Product Engines Continue to Offer Growth Opportunities
n
Enbrel, Prevnar, Nutritionals
New Product Launches Contributing to Revenue Growth
n
Proven Capability in Three R&D Platforms and Proven Ability to
n
Successfully Commercialize and Efficiently Manufacture
Biotech, Vaccine and Traditional Pharma
Pipeline Offers Range of Options Including Both Near-Term and
n
Blockbuster Candidates
Positioned to Take Advantage of Global Growth Opportunities
n
Wyeth: A Diversified Biopharmaceutical Company