wyeth j.p. morgan 26th annual healthcare conference
TRANSCRIPT
Justin R. VictoriaVice President, Investor Relations
Joseph S. Camardo, M.D.Senior Vice President Global Medical Affairs and North American Medical Director, Wyeth Pharmaceuticals
J.P. Morgan 26J.P. Morgan 26thth Annual Annual Healthcare ConferenceHealthcare Conference
January 8, 2008January 8, 2008
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Forward-Looking Statement
The statements in this presentation that are not historical facts are forward-looking statements based on current expectations of future events that involve risks and uncertainties including, without limitation, risks associated with the inherent uncertainty of pharmaceutical research, product development, manufacturing, commercialization, economic conditions including interest and currency exchange rate fluctuations, the impact of competitive or generic products, product liability and other types of lawsuits, the impact of legislative and regulatory compliance and obtaining approvals, and patent, and other risks and uncertainties, including those detailed from time to time in Wyeth’s periodic reports, including quarterly reports on Form 10-Q and the annual report on Form 10-K, filed with the Securities and Exchange Commission. Quarterly results, in particular, can vary due to issues which include, but are not limited to, changes in exchange rates, the timing of actions taken by the Company to ensure long-term improvements to our manufacturing processes, the timing of regulatory approval of new products and/or facilities and the timing of promotional programs. Actual results may vary materially from the forward-looking statements. The Company assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
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+10%+7%$2.74$0.90
Diluted Earnings Per Share
29.3%29.6%Tax Rate+18%+14%Operating Profit+9%+5%R&D Expense+4%+8%SG&A Expense
73.3%73.2%Gross Margin+10%+9%Net Revenue
YTD 20073Q 2007
*Adjusted to Exclude Certain Significant Item. See Press Release Issued October 18, 2007
Wyeth Performance: 3rd Quarter and Nine Months 2007 - Key Financial Elements*
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(in millions)
$0 $500 $1,000 $1,500 $2,000 $2,500 $3,000 $3,500 $4,000 $4,500
Rapamune
BMP-2
BeneFIX
Premarin
Zosyn
Alliance Rev.
Nutritionals
Protonix
Prevnar
Effexor
Enbrel
+0%
+17%
+18%
+5%
+29%
+1%
+22%
0%
+8%
+23%
$3.9 B
$2.8 B
$1.9 B
$1.4 B
$1.1 B
$973 M
$845 M
$791 M
$284M
$265 M
$2.4 B (Amgen) $1.5 B (Wyeth)
$304 M +16%
Strong Performance For Nine Months 2007
YTD 2007 PharmaRevenue +11%
Marketed Products
Biotech Revenues +26%
YTD 07
Biotech Now Represents 36% of Total Pharma
Revenues
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Key Franchises – Growth DriversSupported by New Data
n Helping Patients Live Life Less Interrupted by Their Condition (RA, JRA, Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis)
n Extensive Safety/Efficacy and 14 Years of Clinical Experience
n First-in-Class Pneumococcal Conjugate Vaccine
n Launched in 86 Countries
n Tens of Millions of Children Immunized and Thousands of Lives Saved
*Source: IMS Midas Audited Sales for Enbrel – Rolling Four Quarter Period Ending 3Q07
*
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Wyeth’s Current/Near Term Opportunities: Approved, in Review and Upcoming
Tygacil™(CAP)
ReFacto® AF
Methylnaltrexone (Subcutaneous)
Pristiq™
Depression
Viviant™
Osteoporosis Prevention & Treatment
Pending FDA Pending FDA ApprovalApproval
Torisel™
Lybrel™
Recent FDA Recent FDA ApprovalsApprovals
Tygacil™(HAP)
Bifeprunox
Pristiq™
Vasomotor Symptoms
Pending Pending Further TrialsFurther Trials
Prevnar 13v Adult
Prevnar 13v Infant
Methylnaltrexone (I.V.)
Aprela™
Menopausal Symptoms & Osteoporosis
Key Key Upcoming Upcoming
SubmissionsSubmissions
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Prevnar 13v – Expanding the Coverage
> $1.5 Billion> $3 BillionPeak Sales
n Proof of Concept Achieved
n Licensing Criteria Agreed Upon
n Worldwide Phase 3 Studies Ongoing
n Submission Late 2009
n Phase 2 Proof of Concept Achieved
n Licensing Criteria Agreed Upon
n Worldwide Phase 3 StudiesOngoing
n Submission Early 2009
Status
Provide First and Only Conjugate Vaccine That Offers Adults, Age 50 and Above, an Opportunity to Prevent Pneumococcal Pneumonia for the Rest of Their Lives
Provide Broadest Coverage Available for the Global Protection of Children Against Pneumococcal DiseaseOpportunity
AdultInfant
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Confidence in Future Growth
n COMET Is the First in a Series of Phase IV Studies to Be Released in the Next Few Years
n COMET Evaluated Enbrel/Methotrexate Combination for Patients With Early Severe Rheumatoid Arthritis
n COMET Is First Major Study With Clinical Endpoint of RA Remission
n COMET Demonstrated Excellent Activity to Reduce Disease Activity, Improve Health Associated Quality of Life, and Improve Work Productivity
New Data and Ongoing Stream of Phase IV Studies
COMET – COmbination of Methotrexate and ETanercept in Active Early Rheumatoid Arthritis
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COMET: Enbrel/Methotrexate Induces Remission and Low Disease Activity (LDA)
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41
50
64
0
20
40
60
80
DAS28 Remission DAS28 LDA
% o
f Sub
ject
s
Methotrexate (n=263)Enbrel + Methotrexate (n=265)
*
*p<0.001
*
At One Year
50% Remission
DAS28 = Mean Disease Activity Score
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Wyeth’s Current/Near Term Opportunities: Approved, in Review and Upcoming
Tygacil™(CAP)
ReFacto® AF
Methylnaltrexone (Subcutaneous)
Pristiq™
Depression
Viviant™
Osteoporosis Prevention & Treatment
Pending FDA Pending FDA ApprovalApproval
Torisel™
Lybrel™
Recent FDA Recent FDA ApprovalsApprovals
Tygacil™(HAP)
Bifeprunox
Pristiq™
Vasomotor Symptoms
Pending Pending Further TrialsFurther Trials
Prevnar 13v Adult
Prevnar 13v Infant
Methylnaltrexone (I.V.)
Aprela™
Menopausal Symptoms & Osteoporosis
Key Key Upcoming Upcoming
SubmissionsSubmissions
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626 Patients With AdvancedMetastatic RCC With Poor-Risk Features
RANDOMIZE
Interferon: Escalating to 18 MU SC TIW
Torisel™: 25 mg IV QW
Torisel: 15 mg IV QW+ Interferon: 6 MU SC TIW
n = 207
n = 209
n = 210
Hudes et al. NEJM. 2007; 356: 2271-2281. Data on File, Wyeth Research.
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0.0078
49%
10.9 mo
143209
ToriselTorisel
210207Patients
0.6965Log Rank p-Value Stratified
8.4 mo7.3 moMedian Overall Survival
15%
152
InterferonInterferon+ Torisel+ Torisel
149
InterferonInterferon
% Improvement in Survival
# Deaths
Allows Patients to Live LongerPrimary Efficacy Analysis (446 Deaths)
Hudes et al. NEJM. 2007; 356: 2271-2281. Data on File, Wyeth Research.
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As Important As Survival: Torisel™ Is Safe and Well Tolerated in Patients
n Common Side Effects: Mucositis, Anemia,Hyperlipidemia, Rash, Infection4Treatable and Most Often Did Not Require Dose Modification
n Fewer Patients Were Discontinued Due toSide Effects Relative to Interferon (18% vs. 30%)
n Fewer Patients Had Serious Side Effects Relative to Interferon (38% vs. 48%)
n Fewer Patients Required Dose Reduction Relative to Interferon (20% vs. 38%)
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Torisel™ Phase IV: How to Improve Outcomes in Patients Who Need Second-Line Treatment
RANDOMIZE
Second-Line mRCC
Sutent Failures
Torisel 25 mg IV Weekly (n=220)
Nexavar 400 mg PO bid (n=220)
1:1
Global Trial With Patient Enrollment
In U.S. Sites Currently Underway
Study 404
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Torisel™ Has Significant Potential for Expanded Medical Impact and Growth
n Torisel Is the Only New Drug for Renal Cell Cancer Proven to Extend Survival
n Study 404 in Second-Line Sutent Failures Currently Enrolling4Data Will Be Available in 20094Second-Line Use Represents ~50% of Projected 2010 Sales
n Registration for Mantle Cell Lymphoma Was Submitted in Europe in December 2007
Torisel Peak Sales > $500 Million
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Torisel™ Will Be Followed by Other New Drugs From the Strong Oncology Pipeline
n Phase 3 Started for Two Products in December 20074CMC-544: Targeted Calicheamicin Conjugate for Follicular Lymphoma
4SKI-606 (Bosutinub): Targeted Kinase Inhibitor for Chronic MyelogenousLeukemia
- This Is a Comparative Study With Gleevec for First-Line Treatment
n Phase 2 Is Completing for Next Oncology Product4HKI-272: New Kinase Inhibitor for Breast Cancer
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Wyeth’s Current/Near Term Opportunities: Approved, in Review and Upcoming
Tygacil™(CAP)
ReFacto® AF
Methylnaltrexone (Subcutaneous)
Pristiq™
Depression
Viviant™
Osteoporosis Prevention & Treatment
Pending FDA Pending FDA ApprovalApproval
Torisel™
Lybrel™
Recent FDA Recent FDA ApprovalsApprovals
Tygacil™(HAP)
Bifeprunox
Pristiq™
Vasomotor Symptoms
Pending Pending Further TrialsFurther Trials
Prevnar 13v Adult
Prevnar 13v Infant
Methylnaltrexone (I.V.)
Aprela™
Menopausal Symptoms & Osteoporosis
Key Key Upcoming Upcoming
SubmissionsSubmissions
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Pristiq™ Is Effective for Treating Depression at 50mg
HAM-D17 - Adjusted Mean Total Scores Over Time
Time (Weeks)
Adj
uste
d M
ean
Tot
al S
core
0 2 4 6 8 Endpoint
1015
2025
PlaceboDVS SR 50 mgDVS SR 100 mg
Final(LOCF)
a,b
a,ba,b
a,bab
: p-Value DVS 50mg vs. placebo <= 0.05: p-Value DVS 100mg vs. placebo <= 0.05
Study 333
Presented December 12, 2007
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Pristiq™: Nausea Is Limited to the Early Part of the Treatment Period
0
5
10
15
20
25
Day 1-7 Day 8-14
Day 15-21
Day 22-28
Day 29-42
Day 43-56
Day >56
Poststudy
PlaceboDVS SR 50 mgDVS SR 100 mg
Study 333
% P
atie
nts
Rep
ortin
g N
ause
a as
Tre
atm
ent
Em
erge
nt A
dver
se E
vent
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Pristiq™ Tolerability – Nausea
n Nausea - Tolerability Issue Common to SNRI Classn Occurs in About 1/5 of Patients Treated with Pristiq
50 mg – Low Rate4Nausea Incidence in Combined Study Data for 50 mg Is 22% (vs. 11%
Placebo)- Two Low Dose (50 mg) Fixed Dose Studies
4Compared to Nausea Incidence of 35% to 41% in Previously Reported Fixed Dose Studies 100 to 400 mg
n Nausea Is Mostly Mild or Moderaten Abates in About One Weekn Does Not Lead to Excess Discontinuation of Therapyn Allows Patients to Tolerate the Drug and Get the
Antidepressant Benefit of the Treatment
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Low Dose Program for Pristiq™ – A StrongAddition to the NDA Database for Launch
n Efficacy4Replicate Evidence of Efficacy at 50 mg and 100 mg
4Efficacy Observed As Early As Week 4 for Both Doses- Comparable to Current Antidepressant Therapy
n Safety4Reduced Adverse-Event Related Discontinuation Withdrawal Rates
Compared With Higher Doses
4Improvement in Incidence of Nausea and Overall Tolerability
4No New Safety Signals Seen in Labs, Vital Signs or ECG Parameters
Pristiq MDD NDA Action Date – End February 2008
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Wyeth’s Current/Near Term Opportunities: Approved, in Review and Upcoming
Tygacil™(CAP)
ReFacto® AF
Methylnaltrexone (Subcutaneous)
Pristiq™
Depression
Viviant™
Osteoporosis Prevention & Treatment
Pending FDA Pending FDA ApprovalApproval
Torisel™
Lybrel™
Recent FDA Recent FDA ApprovalsApprovals
Tygacil™(HAP)
Bifeprunox
Pristiq™
Vasomotor Symptoms
Pending Pending Further TrialsFurther Trials
Prevnar 13v Adult
Prevnar 13v Infant
Methylnaltrexone (I.V.)
Aprela™
Menopausal Symptoms & Osteoporosis
Key Key Upcoming Upcoming
SubmissionsSubmissions
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Methylnaltrexone: Significant Unmet Medical Need in Opioid Induced Constipation and Post Operative Ileus
Opioid Induced Constipation (OIC)n A Common Side Effect That Can Be a Barrier to Effective Pain
Managementn First Indication for Methylnaltrexone Will Be for Treatment of OIC
in Patients Receiving Palliative Caren Studies Ongoing for OIC Patients With Chronic Non-Malignant
Pain, and for Shorter Term Acute Pain That Requires Opiates, e.g. Post-Operative OIC in Orthopedic Surgical Patients
Post Operative Ileus (POI)n A Complication of Surgery That Delays Recovery and Can Extend
Hospital Stayn No Medicines Approved to Treat POI
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Importance of Opiates for Pain Creates Substantial Opportunity for Innovative New Product
In U.S. 5 Million Patients Have Opioid Induced Constipation
4.6M4.6M
7.2M7.2M
Continuous UseContinuous Use
Long-Term UseLong-Term Use
~12M Patients Continuous or
Long-Term Use†
>40% Patients Experience
OIC
5.0 Million
Patients
5.0 Million
Patients
OICPopulation
(Est.)
† Longitudinal Patient Data – Opioid Use Days Per Annum: Short -Term = <60 days, Long-Term = 61 – 300 days, &Continuous = 300+ days
(Wyeth Estimates)
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HO O
N
OH
CH3
Morphine
Methylnaltrexone Is a Peripherally Selective Opioid Antagonist
Methylnaltrexone
HO O
N+
HO
O
CH3
n Morphine Acts Centrally and Peripherally
n Methylnaltrexone Is a MuOpioid Receptor Antagonist
n Does Not Cross theBlood-Brain Barrier
n Antagonizes Peripheral, but Not Central OpioidReceptors
n Reverses Opioid Induced Constipation Without Reversing Analgesia or Inducing Withdrawal
Opioids Activate Receptorsin the Brain and ProvidePain Relief…
… But Receptor Activationin the GI Tract Results inConstipation.
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0
10
20
30
40
50
60
70
Placebo 0.15 mg/kg 0.30 mg/kg
% P
atie
nts
Hav
ing
Bo
wel
Mo
vem
ent
Methylnaltrexone Is Effective in Relieving Constipation in Patients Who Need Opiates
>50% of Patients Have Bowel MovementWithin 4 Hours (Study 301)
Recommended Dose
Subcutaneous Methylnaltrexone
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Methylnaltrexone Induces a Rapid and Predictable Response in OIC
Recommended Dose
% P
atie
nts
Hav
ing
B
ow
el M
ove
men
t
Hours
0%
25%
50%
75%
0 1 2 3 4 5
0.30 mg/kg30 minutes
0.15 mg/kg
Placebo
Study 301Subcutaneous Methylnaltrexone
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23 HoursFirst Bowel Movement (p=0.01)
25 HoursTolerance of First Solid Meal (p=0.12)
Acceleration Acceleration (On Average)(On Average)Time to PostTime to Post--operative Recovery Endpointoperative Recovery Endpoint
n 65 Patients With Segmental Colectomies n Randomized to Methylnaltrexone IV or Placebon Evaluated for Clinical Signs Indicating Recovery of Bowel Function and
Readiness for Discharge
Methylnaltrexone IV Accelerates Recovery in Post Operative Ileus (POI): Phase 2 Data
25 HoursActual Discharge (p=0.09)
30 HoursDischarge Eligibility (p=0.03)
Discharge a Day EarlyDischarge a Day Early
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Methylnaltrexone: Status Summary
n Subcutaneous Product for Palliative Care 4NDA Action Date January 30, 20084European Marketing Application Submitted May 2007
n Intravenous Phase 3 Studies To Complete in 1Q084Two Studies of Post Operative Ileus4NDA Submission Planned For Mid 2008
n Oral Formulation – Phase 24Two Studies in OIC Patients with Chronic Non-Malignant Pain
n Additional Phase 3 and Phase 4 Studies for Subcutaneous Product in OIC4Chronic Non-Malignant Pain4Post-Operative OIC in Orthopedic Surgical Patients
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Wyeth R&D: New Drugs With Important Indications
Alzheimer’s DiseaseBapineuzumab
Schizophrenia MaintenanceBifeprunox
Infant/Adult Invasive Pneumococcal DiseasePrevnar 13
Menopausal SymptomsPristiq™
Menopausal Symptoms/OsteoporosisAprela™
CAP/HAPTygacil®
SC – Opioid Induced ConstipationIV – Post Operative Ileus
Methylnaltrexone
Prevention/Treatment OsteoporosisViviant™Major Depressive DisorderPristiq™
Late Stage Pipeline Includes:
ContraceptionLybrel™Renal Cell CancerTorisel™Complicated Skin & Abdominal InfectionsTygacil®
Launched:
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Alzheimer’s DiseaseBapineuzumab
Schizophrenia MaintenanceBifeprunox
Infant/Adult Invasive Pneumococcal DiseasePrevnar 13
Menopausal SymptomsPristiq™
Menopausal Symptoms/OsteoporosisAprela™
CAP/HAPTygacil®
SC – Opioid Induced ConstipationIV – Post Operative Ileus
Methylnaltrexone
Prevention/Treatment OsteoporosisViviant™Major Depressive DisorderPristiq™
Late Stage Pipeline Includes:
ContraceptionLybrel™Renal Cell CancerTorisel™Complicated Skin & Abdominal InfectionsTygacil®
Launched:
Wyeth R&D: New Drugs With Important Indications
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Bapineuzumab Phase 3 for Alzheimer’s Diseasen Four Studies in Over 4,000 Patients Are Beginning
Worldwide4First U.S. Patient Enrolled December 2007; International Studies to Initiate
Early 20084Patients Are Stratified by APO E-4 Carriers vs. Non-Carriers 4APO E-4 Carriers
- 0.5mg/kg vs. Placebo- Minimize Occurrence of Vasogenic Edema
4APO E-4 Non-Carriers- 0.5 mg/kg, 1.0 mg/kg and 2.0 mg/kg vs. Placebo
n Co-Primary Efficacy Endpoints – Validated Cognitive and Functional Scales4Other Cognitive, Functional, Behavioral, Biomarkers, Health Outcomes
Endpoints
n Phase 2 Data Mid-2008
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Conclusion
n Strong Growth Drivers in the Market
n Successful New Product Launches
n A Series of New Products Pending Approval
n Innovative Therapies in Development To Address A Number of High Unmet Medical Needs with Significant Commercial Potential