wyeth credit suisse group healthcare conference

19
Michael E. Kamarck, Ph.D. Executive Vice President, Technical Ops and Product Supply Credit Suisse Healthcare Credit Suisse Healthcare Conference Conference November 12, 2008 November 12, 2008

Upload: finance12

Post on 22-Jun-2015

792 views

Category:

Economy & Finance


7 download

TRANSCRIPT

Page 1: 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

Page 2: wyeth Credit Suisse Group Healthcare Conference

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.

Page 3: wyeth Credit Suisse Group Healthcare Conference

A A Diversified Diversified

Biopharmaceutical Biopharmaceutical CompanyCompany

Page 4: wyeth Credit Suisse Group Healthcare Conference

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

Page 5: wyeth Credit Suisse Group Healthcare Conference

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%

®®

Page 6: wyeth Credit Suisse Group Healthcare Conference

Diverse Manufacturing Platforms With Industry Leading Capacities and

Capabilities

Wyeth Biopharma Manufacturing

Page 7: wyeth Credit Suisse Group Healthcare Conference

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

Page 8: wyeth Credit Suisse Group Healthcare Conference

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

Page 9: wyeth Credit Suisse Group Healthcare Conference

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

Page 10: wyeth Credit Suisse Group Healthcare Conference

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

Page 11: wyeth Credit Suisse Group Healthcare Conference

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

Page 12: wyeth Credit Suisse Group Healthcare Conference

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

Page 13: wyeth Credit Suisse Group Healthcare Conference

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”

Page 14: wyeth Credit Suisse Group Healthcare Conference

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

Page 15: wyeth Credit Suisse Group Healthcare Conference

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

Page 16: wyeth Credit Suisse Group Healthcare Conference

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

®®

Page 17: wyeth Credit Suisse Group Healthcare Conference

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

Page 18: wyeth Credit Suisse Group Healthcare Conference

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

Page 19: wyeth Credit Suisse Group Healthcare Conference

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