wyeth 1st Quarter Earnings Presentation

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wyeth 1st Quarter Earnings Presentation

  1. 1. 1st Quarter 2007 Earnings April 19, 2007
  2. 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. In particular, the statements in this presentation regarding clinical data and/or the regulatory status of our pipeline products are based on a preliminary analysis of the data and our expectations as to how that data will impact the regulatory approval process, which is subject to risks and uncertainties related to both the timing and success of regulatory approval. In addition, although it remains our goal to resolve the issues raised in the Warning Letter relating to our Guayama, Puerto Rico facility as quickly as possible, we cannot exclude the possibility that these issues will result in further regulatory action or delays in the approval of new products or release of approved products manufactured at the facility. Other risks and uncertainties include the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products, including with respect to our pipeline products; government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; data generated on our products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; economic conditions including interest and currency exchange rate fluctuations; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption “Item 1A, Risk Factors.” The forward-looking statements in this presentation are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
  3. 3. 1st Quarter 2007 – Key Financial Elements* Net Revenue +11% Gross Margin 73.1% SG&A Expenses +3% R&D Expense +10% Operating Profit +22% Tax Rate 28% Diluted Earnings Per Share +12% *Adjusted to Exclude Certain Significant Items See Press Release Issued April 19, 2007
  4. 4. Net Revenue Growth Total Wyeth Revenue Increased 11% Pharmaceutical Revenue +11% Consumer Healthcare Revenue +10% Animal Health Revenue +11%
  5. 5. 1st Quarter Product Revenue Performance Prevnar® +43% Enbrel® Int’l. +33% Effexor® -6% Protonix® -2% Premarin® Family -9% Nutritionals +20% Zosyn® +18%
  6. 6. Pristiq™ for Vasomotor Symptoms Previous FDA Action Date – April 23, 2007 n Submitted Results From Study of 100 mg and 150 mg n Doses With Three-day 50 mg Titration 4Markedly Reduced Incidence of Nausea and Adverse Event Related Discontinuations 4Confirmed Efficacy of the 100 mg and 150 mg Doses Next Steps n 4FDA Extended Review Cycle by Three Months to Late July 4Preparing for a U.S. Launch in the 3rd Quarter 2007 4New Data Will Also Be Submitted to European Regulatory Authorities
  7. 7. Pristiq™ for Depression Approvable Letter – January 22, 2007 n Excellent Results Achieved With Low Dose Studies n 4Demonstrated Efficacy at 50 mg Dose 4Replicated Efficacy at 100 mg Dose 4Reduction in Adverse Event Related Discontinuation Rates 4Substantial Improvement in Nausea Rates and Overall Tolerability Next Steps n 4Submit Complete Response Letter by End of August 2007 - Allows for Processing of Final Clinical Reports and Integration of Data Into Overall Safety and Efficacy Analyses 4Expect Six Month Extension to Review Cycle to 1st Quarter 2008 4Preparing for Launch Shortly After Approval
  8. 8. Lybrel™ for Contraception FDA Action Date – May 2007 n Anticipate Approval for Contraception With A n Continuous Regimen … Potential to Eliminate Menstrual Bleeding 4Relief of Cycle Related Symptoms Will Not Be Included in This Initial Approval Next Steps n 4Preparing for a U.S. Launch by Mid-Year 2007 4Mutual Recognition Procedure for European Approval Underway
  9. 9. Viviant™ for Osteoporosis Prevention FDA Action Date – April 23, 2007 n 4Expect FDA to Issue an Approvable Letter Three Year Fracture Study Completed n 4Significant Reduction in the Incidence of Vertebral Fractures 4Significant Increase in Bone Mineral Density 4Reinforced Favorable Safety Profile Next Steps n 4Submission of Three Year Fracture Study by Mid-2007 4Expect Six Month Extension to Review Cycle to Year-End 2007 4European Filing for Osteoporosis Prevention and Treatment Planned for Later in 2007 4U.S. Submission for Osteoporosis Treatment Planned for Later in 2007
  10. 10. Aprela™ for Osteoporosis and Vasomotor Symptoms FDA Filing Planned for Year-End 2007 n Completed Another Phase 3 Clinical Trial n 4Confirmed High Degree of Efficacy in Treating Vasomotor Symptoms 4Pleased With Safety Results for Breast and Endometrium 4Favorable Overall Tolerability Profile
  11. 11. Other Products Pending FDA Review Bifeprunox n 4Filed for Schizophrenia with FDA in October 2006 4Review is Ongoing and Tracking Towards the August Action Date Methylnaltrexone n 4Subcutaneous Formulation for the Treatment of Opioid-Induced Constipation in Patients Receiving Palliative Care Filed With FDA in March 2007 Torisel™ n 4Additional Analyses on Tumor Progression Submitted to FDA - Analyses Did Not Involve the Primary Endpoint of Overall Survival 4Review Cycle for Renal Cell Cancer Extended to July 2007 … Approval Expected
  12. 12. Upcoming Filings Tygacil ® n 4Community Acquired and Hospital Acquired Pneumonia Studies Being Analyzed 4On Track for Mid-Year Filing Prevnar 13 n 4Infant and Adult Phase 3 Programs Underway 4Progressing Towards Planned 2009 Filings
  13. 13. Summary Another Excellent Quarter for Wyeth n 4 All Businesses Showed Strong Growth Enbrel and Prevnar Were Strong Contributors n Continue to Work Towards a Timely Resolution of FDA’s Concerns n Regarding the Guayama Facility and We Do Not See Any Impact on the Timing of Our New Product Launches Received Important New Clinical Results for Several Late Stage Pipeline n Products The Recently Completed Studies on Pristiq, Viviant and Aprela Will n Significantly Contribute to the Approval, Initial Positioning and Profiling of These New Products

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