wyeth Credit Suisse Group Healthcare Conference
-
Upload
finance12 -
Category
Economy & Finance
-
view
791 -
download
7
Transcript of wyeth Credit Suisse Group Healthcare Conference
Michael E. Kamarck, Ph.D.Executive Vice President,Technical Ops and Product Supply
Credit Suisse Healthcare Credit Suisse Healthcare ConferenceConference
November 12, 2008November 12, 2008
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 "Item 1A, Risk Factors." Wyeth assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
A A Diversified Diversified
Biopharmaceutical Biopharmaceutical CompanyCompany
Wyeth’s Diversification … A Key Asset
n Diverse Scientific PlatformsPharmaceuticals, Biotechnology, Vaccines
n Diverse Business PlatformsBiotech, Vaccines, Nutritionals, Consumer Healthcare, Animal Healthcare = 60% of Revenue in 2008Growing to 75% by 2012
n Diverse Therapeutic Approaches
Treatment vs. Disease PreventionPreventative Therapies
- Human and Animal Vaccines, Infant Formula, Vitamins, Supplements
40%
36%
7%12%5%
0%
20%
40%
60%
80%
100%
YTD 2008%
of R
even
ue
Pharma Biotech/VaccinesNutritionals ConsumerAnimal Health
60% Non-Traditional
Pharma
Core Biotech/Vaccine Franchises with High Growth Potential
n ~$6 Billion Global Sales in 2008n #1 Worldwide Biotech Brandn $10 Billion RA/Psoriasis
Biological Market Expansion by 2012
n Maintain #1 Position in Category Due to Established Safety and Efficacy Profile
n 31 National Immunization Programs in Place … on the Market in 89 Countries
n Prevnar 13 Filing for Infants 2009; For Adults 2010
n Manufacturing Capacity Strong and Growing
60 Million Doses in 2008 Future Manufacturing Capacity growing to 120 Million Doses
Wyeth - A Leading Biotech Company GloballyBiotech/Vaccine Revenue YTD08 = $6.3 Billion, +20%
®®
Diverse Manufacturing Platforms With Industry Leading Capacities and
Capabilities
Wyeth Biopharma Manufacturing
Traditional Pharma vs. Biotech Drugs/Vaccines
Traditional PharmaTraditional PharmaBiotech Drugs & Biotech Drugs & New Generation New Generation
VaccinesVaccines
Size and Complexity Small Chemical Molecules 100 to 1000X Larger
Manufactured By Chemistry By Living Cells
Sterility of Process Chemical Conditions Often Kill Bacteria
All Steps Support Bacterial Growth
Delivery Mechanism Usually Tablets or Capsules
Injected or Other Special Delivery
Maturity of Industry >100 Years ~25 Years
Wyeth Has Been A Leader in Biotech Manufacturing Since 1983
Wyeth Biotech Network
n We Have Invested Over $3.5 Billion in Network Infrastructure Between 2000 and 2007 in Support of Product Launch and Growth
n In Parallel, We Have Focused on Process Development Working on the Premise That “Biology Will Trump Stainless Steel”
n With These Improvements, the Existing Infrastructure Can Sustainthe Continued Growth
Sanford Sanford NCNC
Grange Castle Grange Castle IrelandIreland
Andover Andover MAMA
Pearl River Pearl River NYNY
Algete Algete SpainSpain
HavantHavantUKUK
ESNESN33rdrd PartiesParties
Biotech Process Development
n Over 25 Years of Biotech Development Experience
>500 R&D Scientists
n 30 Different Protein Products Brought Into the Clinic
n Drug Substance and Drug Product Development Facilities
Research Labs – 140,000 Sq Ft Pilot Scale Laboratories in the U.S. and IrelandClinical Manufacturing Facilities – in MA and NC
Cell Line Development
n Pre-adapted CHO Hostn Industrialized and Automated Cell
Line Development and Constructionn Proprietary Fermentation
Technology Increases Outputs From:
0.5 – 1 g/l – 20011 – 3 g/l – 20023 – 5 g/l – 200410 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, thestandard was 1 gram per liter.” Nature Biotechnology, September 2006
n Bioreactor TechnologyProprietary, Defined Medium (Animal Protein-free)
Capable of Supporting Highest-density Cultures
n Purification TechnologyProprietary 2-column MAb Purification Process
n Seamless Technical Transfer of Process From Lab Bench to Manufacturing
Bioreactor and Purification Process Development
Clinical Production Suites
n 38,000 sq ft cGMP Multi-product Manufacturing
n Equipment/cGMP Systems to Manufacture Two Products Simultaneously
n Cell Culture Bioreactor Hall1 X 6000 L
2 X 2500 L
1 X 500 L
n Purification “Suites” Match Bioreactor Capacityn Support up to Ten Campaigns Per Year for Both Clinical
and Future Commercial Products
Industry-Leading Platform Technology
n Upstream and Downstream Standard Process Platform EstablishedAll Cell Lines Derived From Same Host
All Proteins Produced From the Identical Process Flow
Using the Same Raw Materials, Filters, Buffers, Resins
n 35% Reduction in Gene to IND Timeline – Product Changeover in Days
n Single Facility Configuration Can Manufacture All Pipeline and Commercial Products
n Wyeth Received the 2008 ACS Industrial Biotechnology Award Given by the Biotechnology Division of the American Chemical Society Honoring Distinguished Industrial Accomplishments in Biotechnology
n Awarded to Wyeth: “in Recognition of Their Achievements in Implementing Industry-leading Platform Technology”
Biology Trumps Stainless Steel
n Our Investments Are in Process Standardization and Upstream/downstream Process Efficiencies and Yields
n We Have Implemented the Platform For All Our Pipeline Products
n We Have Established a Proprietary Portfolio of Process Technologies
n We Have Utilized Our Technology Advances in Improving Our Existing Commercial Products
Biology Trumps Stainless Steel: Commercial Examples
Product New Yields Approval Date
Enbrel 150% Feb 2008 - EMEA
Xyntha 200% Feb 2008 - US
BMP-2 >200% Nov 2007 – EMEA March 2008 - US
n Meets Projected Upside Demand Without Additional Capital Investment
n Increases Capacity for Pipeline Productsn Improves Plant and Product Cost Structure
n Have Developed Process for Prevnar 13vn Produced 13v Clinical Trial Material; Phase 3 Trials Have Been
Successfully Completedn Invested in Staff and Equipment in Five Facilities in Support of
Launchn In 2008, We Manufactured Launch Supply of 13v From All
Facilities n We Have Completed 1200 Technical Documents in Support of Our
Filing for Infants … Planned by Early 2009n We Have Identified Process Improvements to Allow Us to
Ultimately Manufacture up to 120 MM Doses of 13v From Our Existing Facilities
®®
Standardized Technology Platforms for Traditional Pharma Products
n Minimize Capital Investment Through Utilization of One Multi-product Launch Module vs. Building Multiple Product-dedicated Modules
n Improve Existing Large Volume Asset Utilization by Leveraging Existing Infrastructure
n Customizing API to Drive Standard Formulationsn Improve Our Flexibility to Expand/Contract Capacity in
Alignment With Product Life Cycle n Align With the Proven Value Demonstrated in Biotech
Standardization
Standard Platforms Selected Based on Long Term Manufacturing Ease and Network Fit
Manufacturing Ease/Cost Advantage
NetworkFit
H
L H
Tablet:Direct
compression
Tablet:Wet
granulation
Capsule:Liquid filled
Modify Excipients orAPI Properties
(Co-Labs)
Modify or Outsource Special Formulation Requirements
Wyeth: Positioning Itself for Future Growth
n Diversified by BusinessPrescription, Consumer, Animal Health
n Primary Product Engines Continue to Offer Growth Opportunities Enbrel, Prevnar, Nutritionals
n New Product Launches Contributing to Revenue Growthn Proven Capability in Three R&D Platforms and Proven Ability to
Successfully Commercialize and Efficiently ManufactureBiotech, Vaccine and Traditional Pharma
n Pipeline Offers Range of Options Including Both Near-Term and Blockbuster Candidates
n Positioned to Take Advantage of Global Growth Opportunities
Wyeth: A Diversified Biopharmaceutical CompanyWyeth: A Diversified Biopharmaceutical Company