This document summarizes a presentation given at the J.P. Morgan 26th Annual Healthcare Conference. It discusses Wyeth's financial performance in Q3 and the first nine months of 2007, with revenue and earnings growth across key franchises like Enbrel, Effexor, Prevnar, and Protonix. It also highlights Wyeth's approved, pending, and upcoming opportunities, including new data on drugs like Pristiq, Torisel, and expanded indications for Prevnar 13. Wyeth expects continued growth from these pharmaceutical products and advancing its oncology pipeline.
20240429 Calibre April 2024 Investor Presentation.pdf
J.P. Morgan 26th Annual Healthcare Conference Wyeth Performance and Pipeline Update
1. J.P. Morgan 26th Annual
Healthcare Conference
Justin R. Victoria
Vice President, Investor Relations
Joseph S. Camardo, M.D.
Senior Vice President Global Medical Affairs
and North American Medical Director, Wyeth
Pharmaceuticals
January 8, 2008
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 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.
2
3.
4. Wyeth Performance: 3rd Quarter and Nine
Months 2007 - Key Financial Elements*
3Q 2007 YTD 2007
Net Revenue +9% +10%
Gross Margin 73.2% 73.3%
SG&A Expense +8% +4%
R&D Expense +5% +9%
Operating Profit +14% +18%
Tax Rate 29.6% 29.3%
$0.90 $2.74
Diluted Earnings Per Share
+7% +10%
*Adjusted to Exclude Certain Significant Item. See Press Release Issued October 18, 2007
4
5. Marketed Products
Strong Performance For Nine Months 2007
Enbrel +22%
$2.4 B (Amgen) $1.5 B (Wyeth) $3.9 B
Effexor +1%
$2.8 B
Prevnar +29%
$1.9 B
Protonix +5%
$1.4 B
YTD 2007 Pharma
Nutritionals +18%
$1.1 B
Revenue +11%
Alliance Rev. 0%
$973 M
Zosyn +17%
$845 M
Biotech
Premarin Biotech Now
+0%
$791 M Revenues +26%
Represents 36%
YTD 07
BeneFIX +16%
$304 M
of Total Pharma
BMP-2 $284M +23% Revenues
Rapamune +8%
$265 M
$0 $500 $1,000 $1,500 $2,000 $2,500 $3,000 $3,500 $4,000 $4,500
(in millions)
5
6. Key Franchises – Growth Drivers
Supported by New Data
*
Helping Patients Live Life Less
First-in-Class Pneumococcal n
n
Interrupted by Their Condition
Conjugate Vaccine
(RA, JRA, Psoriasis, Psoriatic
Launched in 86 Countries
n
Arthritis and Ankylosing
Tens of Millions of Children
n Spondylitis)
Immunized and Thousands of
Extensive Safety/Efficacy and
Lives Saved n
14 Years of Clinical Experience
6 *Source: IMS Midas Audited Sales for Enbrel – Rolling Four Quarter Period Ending 3Q07
7. Wyeth’s Current/Near Term Opportunities:
Approved, in Review and Upcoming
Key
Recent FDA Pending FDA Pending
Upcoming
Further Trials
Approvals Approval
Submissions
Viviant™ Aprela™
Pristiq™
Lybrel ™ Osteoporosis Prevention Menopausal Symptoms &
Vasomotor Symptoms
& Treatment Osteoporosis
Torisel ™ Pristiq™ Bifeprunox Methylnaltrexone
Depression (I.V.)
Prevnar 13v
Tygacil™
Methylnaltrexone
Infant
(Subcutaneous) (HAP)
ReFacto® AF Prevnar 13v
Adult
Tygacil™
(CAP)
7
8. Prevnar 13v – Expanding the Coverage
Infant Adult
Provide Broadest Coverage Provide First and Only Conjugate
Vaccine That Offers Adults, Age
Available for the Global Protection
50 and Above, an Opportunity to
of Children Against Pneumococcal
Opportunity Prevent Pneumococcal
Disease
Pneumonia for the Rest of Their
Lives
Phase 2 Proof of Concept Proof of Concept Achieved
n n
Achieved
Licensing Criteria Agreed
n
Licensing Criteria Agreed Upon Upon
n
Status Worldwide Phase 3 Studies Worldwide Phase 3 Studies
n n
Ongoing Ongoing
Submission Early 2009 Submission Late 2009
n n
> $3 Billion > $1.5 Billion
Peak Sales
8
9. Confidence in Future Growth
New Data and Ongoing Stream of Phase IV Studies
COMET Is the First in a Series of Phase IV Studies to
n
Be Released in the Next Few Years
COMET Evaluated Enbrel/Methotrexate Combination
n
for Patients With Early Severe Rheumatoid Arthritis
COMET Is First Major Study With Clinical Endpoint of
n
RA Remission
COMET Demonstrated Excellent Activity to Reduce
n
Disease Activity, Improve Health Associated Quality of
Life, and Improve Work Productivity
COMET – COmbination of Methotrexate and ETanercept in Active Early
Rheumatoid Arthritis
9
10. COMET: Enbrel/Methotrexate Induces
Remission and Low Disease Activity (LDA)
80 Methotrexate (n=263)
Enbrel + Methotrexate (n=265)
64 *
50%
60 Remission
50 *
% of Subjects
41
40
28
20
0
DAS28 Remission DAS28 LDA
At One Year
*p<0.001
DAS28 = Mean Disease Activity Score
10
11. Wyeth’s Current/Near Term Opportunities:
Approved, in Review and Upcoming
Key
Recent FDA Pending FDA Pending
Upcoming
Further Trials
Approvals Approval
Submissions
Viviant™ Aprela™
Pristiq™
Lybrel ™ Osteoporosis Prevention Menopausal Symptoms &
Vasomotor Symptoms
& Treatment Osteoporosis
Torisel ™ Pristiq™ Bifeprunox Methylnaltrexone
Depression (I.V.)
Prevnar 13v
Tygacil™
Methylnaltrexone
Infant
(Subcutaneous) (HAP)
ReFacto® AF Prevnar 13v
Adult
Tygacil™
(CAP)
11
12. Interferon: Escalating to
R
18 MU SC TIW n = 207
A
626 Patients With
N
Advanced D
Metastatic RCC Torisel ™: 25 mg IV QW
O
With Poor-Risk M n = 209
Features I
Z
Torisel: 15 mg IV QW
E
+ Interferon: 6 MU SC TIW
n = 210
Hudes et al. NEJM. 2007; 356: 2271-2281. Data on File, Wyeth Research.
12
13. Allows Patients to Live Longer
Primary Efficacy Analysis (446 Deaths)
Interferon
Torisel Interferon
+ Torisel
Patients 209 207 210
# Deaths 143 149 152
Median Overall
10.9 mo 7.3 mo 8.4 mo
Survival
% Improvement in
49% 15%
Survival
Log Rank p-Value
0.0078 0.6965
Stratified
Hudes et al. NEJM. 2007; 356: 2271-2281. Data on File, Wyeth Research.
13
14. As Important As Survival: Torisel™ Is Safe
and Well Tolerated in Patients
Common Side Effects: Mucositis, Anemia,
n
Hyperlipidemia, Rash, Infection
4Treatable and Most Often Did Not Require Dose Modification
Fewer Patients Were Discontinued Due to
n
Side Effects Relative to Interferon (18% vs. 30%)
Fewer Patients Had Serious Side Effects Relative to
n
Interferon (38% vs. 48%)
Fewer Patients Required Dose Reduction Relative to
n
Interferon (20% vs. 38%)
14
15. Torisel™ Phase IV: How to Improve Outcomes in
Patients Who Need Second-Line Treatment
Study 404
Torisel 25 mg IV
R
A Weekly (n=220)
N
Second-Line D
mRCC 1:1
O
Sutent Failures M
Nexavar 400 mg
I
PO bid (n=220)
Z
E
Global Trial With Patient Enrollment
In U.S. Sites Currently Underway
15
16. Torisel™ Has Significant Potential for
Expanded Medical Impact and Growth
Torisel Is the Only New Drug for Renal Cell Cancer
n
Proven to Extend Survival
n Study 404 in Second-Line Sutent Failures Currently
Enrolling
4Data Will Be Available in 2009
4Second-Line Use Represents ~50% of Projected 2010 Sales
Registration for Mantle Cell Lymphoma Was Submitted
n
in Europe in December 2007
Torisel Peak Sales > $500 Million
16
17. Torisel™ Will Be Followed by Other New
Drugs From the Strong Oncology Pipeline
Phase 3 Started for Two Products in December 2007
n
4CMC-544: Targeted Calicheamicin Conjugate for Follicular Lymphoma
4SKI-606 (Bosutinub): Targeted Kinase Inhibitor for Chronic Myelogenous
Leukemia
- This Is a Comparative Study With Gleevec for First-Line Treatment
Phase 2 Is Completing for Next Oncology Product
n
4HKI-272: New Kinase Inhibitor for Breast Cancer
17
18. Wyeth’s Current/Near Term Opportunities:
Approved, in Review and Upcoming
Key
Recent FDA Pending FDA Pending
Upcoming
Further Trials
Approvals Approval
Submissions
Viviant™ Aprela™
Pristiq™
Lybrel ™ Osteoporosis Prevention Menopausal Symptoms &
Vasomotor Symptoms
& Treatment Osteoporosis
Torisel ™ Pristiq™ Bifeprunox Methylnaltrexone
Depression (I.V.)
Prevnar 13v
Tygacil™
Methylnaltrexone
Infant
(Subcutaneous) (HAP)
ReFacto® AF Prevnar 13v
Adult
Tygacil™
(CAP)
18
19. Pristiq™ Is Effective for Treating Depression
at 50mg
HAM-D17 - Adjusted Mean Total Scores Over Time
Study 333
25
Placebo
DVS SR 50 mg
DVS SR 100 mg
Adjusted Mean Total Score
20
Final
15
(LOCF)
a,b
10
a : p-Value DVS 50mg vs. placebo <= 0.05
b : p-Value DVS 100mg vs. placebo <= 0.05 a,b a,b
a,b
0 2 4 6 8 Endpoint
Time (Weeks)
Presented December 12, 2007
19
20. Pristiq™: Nausea Is Limited to the Early Part
of the Treatment Period
Study 333
25 Placebo
% Patients Reporting Nausea as Treatment
DVS SR 50 mg
20 DVS SR 100 mg
Emergent Adverse Event
15
10
5
0
Day 1-7 Day 8- Day 15- Day 22- Day 29- Day 43- Day > Post
14 21 28 42 56 56 study
20
21. Pristiq™ Tolerability – Nausea
Nausea - Tolerability Issue Common to SNRI Class
n
n Occurs in About 1/5 of Patients Treated with Pristiq
50 mg – Low Rate
4Nausea 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
Nausea Is Mostly Mild or Moderate
n
n Abates in About One Week
n Does Not Lead to Excess Discontinuation of Therapy
n Allows Patients to Tolerate the Drug and Get the
Antidepressant Benefit of the Treatment
21
22. Low Dose Program for Pristiq™ – A Strong
Addition to the NDA Database for Launch
Efficacy
n
4Replicate Evidence of Efficacy at 50 mg and 100 mg
4Efficacy Observed As Early As Week 4 for Both Doses
- Comparable to Current Antidepressant Therapy
Safety
n
4Reduced 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
22
23. Wyeth’s Current/Near Term Opportunities:
Approved, in Review and Upcoming
Key
Recent FDA Pending FDA Pending
Upcoming
Further Trials
Approvals Approval
Submissions
Viviant™ Aprela™
Pristiq™
Lybrel ™ Osteoporosis Prevention Menopausal Symptoms &
Vasomotor Symptoms
& Treatment Osteoporosis
Torisel ™ Pristiq™ Bifeprunox Methylnaltrexone
Depression (I.V.)
Prevnar 13v
Tygacil™
Methylnaltrexone
Infant
(Subcutaneous) (HAP)
ReFacto® AF Prevnar 13v
Adult
Tygacil™
(CAP)
23
24. Methylnaltrexone: Significant Unmet Medical Need in
Opioid Induced Constipation and Post Operative Ileus
Opioid Induced Constipation (OIC)
A Common Side Effect That Can Be a Barrier to Effective Pain
n
Management
First Indication for Methylnaltrexone Will Be for Treatment of OIC
n
in Patients Receiving Palliative Care
Studies Ongoing for OIC Patients With Chronic Non-Malignant
n
Pain, and for Shorter Term Acute Pain That Requires Opiates,
e.g. Post-Operative OIC in Orthopedic Surgical Patients
Post Operative Ileus (POI)
A Complication of Surgery That Delays Recovery and Can Extend
n
Hospital Stay
No Medicines Approved to Treat POI
n
24
25. Importance of Opiates for Pain Creates Substantial
Opportunity for Innovative New Product
In U.S. 5 Million Patients Have Opioid Induced
Constipation
>40% Patients
~12M Patients OIC
Continuous or Population
Experience
Long-Term Use† (Est.)
OIC
4.6M
5.0
Continuous Use
Million
Patients
7.2M
Long-Term Use
(Wyeth Estimates)
† Longitudinal Patient Data – Opioid Use Days Per Annum: Short -Term = <60 days, Long-Term = 61 – 300 days, &
Continuous = 300+ days
25
26. Methylnaltrexone Is a Peripherally Selective
Opioid Antagonist
CH3
Opioids Activate Receptors
Morphine Acts Centrally
in the Brain and Provide n
Pain Relief…
N and Peripherally
Morphine
n Methylnaltrexone Is a Mu
Opioid Receptor
Antagonist
HO O OH n Does Not Cross the
Blood-Brain Barrier
n Antagonizes Peripheral,
CH3
but Not Central Opioid
Receptors
Methylnaltrexone
N+
n Reverses Opioid Induced
Constipation Without
HO
Reversing Analgesia or
Inducing Withdrawal
… But Receptor Activation
in the GI Tract Results in
HO O O
Constipation.
26
27. Methylnaltrexone Is Effective in Relieving
Constipation in Patients Who Need Opiates
>50% of Patients Have Bowel Movement
Within 4 Hours (Study 301)
70
Subcutaneous Methylnaltrexone
% Patients Having Bowel Movement
60
50
40
30
20
10
0
Placebo 0.15 mg/kg 0.30 mg/kg
Recommended Dose
27
28. Methylnaltrexone Induces a Rapid and
Predictable Response in OIC
Study 301
Subcutaneous Methylnaltrexone
75%
30 minutes
0.30 mg/kg
% Patients Having
Bowel Movement
0.15 mg/kg
50%
25%
Placebo
0%
0 4
1 2 3 5
Hours
Recommended Dose
28
29. Methylnaltrexone IV Accelerates Recovery in
Post Operative Ileus (POI): Phase 2 Data
65 Patients With Segmental Colectomies
n
Randomized to Methylnaltrexone IV or Placebo
n
Evaluated for Clinical Signs Indicating Recovery of Bowel Function and
n
Readiness for Discharge
Acceleration
Time to Post-operative Recovery Endpoint (On Average)
Tolerance of First Solid Meal (p=0.12) 25 Hours
First Bowel Movement (p=0.01) 23 Hours
Discharge Eligibility 30 Hours
(p=0.03)
Actual Discharge 25 Hours
(p=0.09)
Discharge a Day Early
29
30. Methylnaltrexone: Status Summary
Subcutaneous Product for Palliative Care
n
4NDA Action Date January 30, 2008
4European Marketing Application Submitted May 2007
Intravenous Phase 3 Studies To Complete in 1Q08
n
4Two Studies of Post Operative Ileus
4NDA Submission Planned For Mid 2008
Oral Formulation – Phase 2
n
4Two Studies in OIC Patients with Chronic Non-Malignant Pain
Additional Phase 3 and Phase 4 Studies for
n
Subcutaneous Product in OIC
4Chronic Non-Malignant Pain
4Post-Operative OIC in Orthopedic Surgical Patients
30
31. Wyeth R&D: New Drugs With Important
Indications
Launched:
Tygacil® Complicated Skin & Abdominal Infections
Torisel™ Renal Cell Cancer
Lybrel™ Contraception
Late Stage Pipeline Includes:
Pristiq ™ Major Depressive Disorder
Viviant™ Prevention/Treatment Osteoporosis
Methylnaltrexone SC – Opioid Induced Constipation
IV – Post Operative Ileus
Tygacil® CAP/HAP
Aprela ™ Menopausal Symptoms/Osteoporosis
Pristiq ™ Menopausal Symptoms
Prevnar 13 Infant/Adult Invasive Pneumococcal Disease
Bifeprunox Schizophrenia Maintenance
Bapineuzumab Alzheimer’s Disease
31
32. Wyeth R&D: New Drugs With Important
Indications
Launched:
Tygacil® Complicated Skin & Abdominal Infections
Torisel™ Renal Cell Cancer
Lybrel™ Contraception
Late Stage Pipeline Includes:
Pristiq ™ Major Depressive Disorder
Viviant™ Prevention/Treatment Osteoporosis
Methylnaltrexone SC – Opioid Induced Constipation
IV – Post Operative Ileus
Tygacil® CAP/HAP
Aprela ™ Menopausal Symptoms/Osteoporosis
Pristiq ™ Menopausal Symptoms
Prevnar 13 Infant/Adult Invasive Pneumococcal Disease
Bifeprunox Schizophrenia Maintenance
Bapineuzumab Alzheimer’s Disease
32
33. Bapineuzumab Phase 3 for Alzheimer’s
Disease
Four Studies in Over 4,000 Patients Are Beginning
n
Worldwide
4First U.S. Patient Enrolled December 2007; International Studies to Initiate
Early 2008
4Patients 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
Co-Primary Efficacy Endpoints – Validated Cognitive
n
and Functional Scales
4Other Cognitive, Functional, Behavioral, Biomarkers, Health Outcomes
Endpoints
Phase 2 Data Mid-2008
n
33
34. Conclusion
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
n
of High Unmet Medical Needs with Significant Commercial
Potential
34