Pfizer Analyst & Investor Meeting at ICAD


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Pfizer Analyst & Investor Meeting at ICAD

  1. 1. Advancing Neuroscience Analyst & Investor Briefing July 28, 2008 1
  2. 2. Forward-Looking Statements and Non-GAAP Financial Information Discussions at this meeting will include forward-looking statements. Actual results could differ materially from those projected in the forward-looking statements. The factors that could cause actual results to differ are discussed in Pfizer’s 2007 Annual Report on Form 10-K and in our reports on Form 10-Q and Form 8-K. Also, discussions during this meeting may include certain financial measures that were not prepared in accordance with generally accepted accounting principles. Reconciliations of those non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in Pfizer’s Current Report on Form 8-K dated July 23, 2008. These reports are available on our website at in the “Investors—SEC Filings” section. 2
  3. 3. Agenda An Introduction to Pfizer’s Neuroscience Portfolio Pfizer’s Evolving Vision for In-line Products Alpha-2 Delta Platform “Invest to Win” Disease Areas Alzheimer’s disease Schizophrenia / Bipolar Disorder Recap & Future Outlook 3
  4. 4. An Introduction to Pfizer’s Neuroscience Portfolio Steve Romano, MD Vice President, Global Medical 4
  5. 5. Neuroscience Leadership Pfizer Success Factors Market Potential Strong track record + Significant unmet needs in neuroscience Large market opportunities Near-term growth Limited approved therapeutic Valuable in-line portfolio approaches Well-positioned to capitalize on emerging science Innovative Medicines 5
  6. 6. Pfizer Therapeutic Area Priorities Invest to Win Invest to Win First or High Market High Best in Class Growth Unmet Need Alzheimer’s disease Schizophrenia / Bipolar Disorder Pain Diabetes/Obesity Immunology/Inflammation Oncology 6
  7. 7. Pfizer Neuroscience Pipeline Overview Platform Key Alzheimer’s Schizophrenia; Bipolar disorder Alpha-2-delta 9 compounds for Schizophrenia, Other Bipolar disorder and cognition Geodon for RAGE Inhibitor Adjunctive Use in Bipolar Depression LYRICA 6 compounds PDE 10-A Inhibitor Geodon for Bipolar for AD Relapse Prevention CHANTIX D2 Partial Agonist 2 compounds for other indications PD-332,334 for GAD a2d for Sleep GEODON Lyrica for Epilepsy 2 compounds for Lyrica for RLS Monotherapy Smoking Cessation ARICEPT 19 5 4 4 Pre-Clinical Phase II Phase III Approved and Phase I Chantix is referred to as Champix outside the U.S.; Geodon is referred to as Zeldox outside the U.S. 7
  8. 8. An Evolving Vision for In-line Products 8
  9. 9. CHANTIX: Scope of the Worldwide Smoking Epidemic 1.3 Billion Smokers Canada Europe Region 5M 215M Japan 30M U.S. China 45M India >300M >100M Brazil 18M Source: 2008 WHO Estimates 9
  10. 10. CHANTIX: For Smokers Motivated to Quit 45M Smokers 30M Smokers in the U.S. Motivated to Quit Control Immature Takers Quitters 29% 12% 13.0M Desire to Quit Chantix Target MD/Rx- Dependent Defiant Quitters Smokers 37% 22% 16.7M Openness to Medical Intervention 10
  11. 11. CHANTIX: Develop the Smoking Cessation Market to Drive Growth Consumer Professional Communicate the full efficacy/ safety profile of Chantix Educate doctors on the difficulties patients face when quitting smoking Access & Reimbursement Recently launched unbranded ad campaign designed to Drive coverage for smoking educate consumers about: cessation and CHANTIX with payers, including: Nicotine Addiction Commercial plans Role of their doctor State Medicaid Awareness of medication option Employers 11
  12. 12. GEODON: Continues to Generate Growth U.S. Geodon field force Quarterly Sales ($ M) realigned to focus on specialists across treatment settings 300 FY 2007 U.S. sales up 11% 250 to $702 million vs. 2006 200 Total 1H08 sales of $473 150 million 100 50 0 6 6 6 6 7 7 7 7 8 8 10 20 30 40 10 20 30 40 10 20 Q Q Q Q Q Q Q Q Q Q US International 12
  13. 13. GEODON: Pfizer Is Committed to Further Clinical Development BIPOLAR DISORDER PHASE 3 STUDIES Monotherapy studies in Bipolar Depression: Completing Adjunctive use in Bipolar Depression: Study initiated in 2008 Bipolar Relapse Prevention: Ongoing PEDIATRIC EXCLUSIVITY Bipolar Mania: Completed Schizophrenia: Ongoing 13
  14. 14. ARICEPT Continues To Grow And Lead Global Alzheimer’s (AD) Market Total WW MAT*/4/08 Sales Share AD MARKET $6.0 B 100% $7.0 ARICEPT $3.2 B 54% OTHER $2.8 B 46% $6.0 $5.0 $ Billions $4.0 $3.0 $2.0 $1.0 $0.0 4/04 7/04 10/04 1/05 4/05 7/05 10/05 1/06 4/06 7/06 10/06 1/07 4/07 7/07 10/07 1/08 4/08 *Rolling Moving Annual Total - April ‘08 Source: IMS Alzheimers Monthly Sales - April 2008 14
  15. 15. ARICEPT: Major Initiatives Underway Around Early AD Dx and Persistency Mild AD Sufferers Globally Continuing Patients in US Largely Undiagnosed and Untreated Represent Bulk of RX Mild 88% of 72% Patients Moderate Persistent 22% With Rx 7% New 6% Severe 5% Other In US, Germany, France, Italy, Spain, UK, Japan Only 3.58m out of 9.41m total AD sufferers are diagnosed; only 2.45m treated Source: IMS Length of Therapy (July 2007); Omnicare LTC Study (Aug 2006); Aricept Situation Analysis (Jun 2008) Data Monitor 9/04, Skim Analytical Healthcare 2007,Caregiver Segmentation, Ziment 5/07 15
  16. 16. ARICEPT: New U.S. Ad Campaigns Aim to Improve Diagnosis, Treatment, Persistence Unbranded DRTV Branded DTC Launched Feb 2008 Launched June 2008 16
  17. 17. LYRICA: A Young, Strong and Growing Brand 2007 sales totaled $1.8B, +58% Y/Y Quarterly Sales ($ M) Strong global TRx growth 700 Global growth driven by NeP and strong U.S. fibromyalgia launch US Fibromyalgia 600 Approval performance 500 Leadership in neuropathic pain 400 Market leader in DPN/PHN Ranked by physicians to have the 300 highest treatment satisfaction2 200 Established first-line use 100 Robust U.S. launch in fibromyalgia 0 Approved by FDA as the first agent for fibromyalgia in June 2007 6 6 6 6 7 7 7 7 8 8 10 20 30 40 10 20 30 40 10 20 Q Q Q Q Q Q Q Q Q Q EMEA review ongoing US International Source: 1. Q208 vs. Q207 reported sales; 2. US DPN/PHN ATU survey (6/2008) 17
  18. 18. LYRICA Lifecycle Plan: Strengthen Core Indications and Expand 2009+ 2007 Planned Indications Core Indications Traditional NeP Traditional NeP • PHN/DPN Epilepsy • PHN/ DPN • Additional indications • Adjunct GAD Epilepsy (EU) Post-Op • Mono Pain • Pediatric Fibro (US) Fibromyalgia (+EU) RLS GAD (+US) 18
  19. 19. Alpha-2-Delta (a2d) Platform 19
  20. 20. 2 Mechanism of Action *Does not greatly alter Ca++ influx in normal neurons 20
  21. 21. PD-332,334 May Offer a Unique Value Proposition in GAD Fast Sustained Somatic Psychic No Sexual Low Abuse Sleep Onset Effect Symptoms Symptoms Dysfunction Potential Benefits PD-332,334 +/- Benzos SSRI/ +/- SNRIs 21
  22. 22. PD-200,390 a2d for Insomnia Including Non-restorative Sleep in Phase II Studies Core Components of Insomnia Can occur alone or in combination Difficulty Difficulty Initiating Maintaining NRS occurring independent of DIS or DMS can lead to Sleep Sleep significant daytime functional (DMS) (DIS) impairment.2,3 Ongoing clinical development plan includes Non- studies for primary insomnia and NRS Restorative Sleep (NRS) 1DSM-IV TR. American Psychiatric Association, 2000 2Ohayon MM. Arch Intern Med 2005;165:35–41 3Roth T, et al. Biol Psychiatry 2006;60:1364–71 22
  23. 23. NRS Methodology Study (presented at APSS June 2008) Study validated a population with NRS in the absence of DIS or DMS, by objective PSG assessment NRS-only subjects’ PSG-measured sleep parameters matched those of healthy control subjects, but this group exhibited daytime functional impairment similar to that seen in subjects with DIS and/or DMS This study demonstrates the presence of a patient population experiencing daytime functional impairment that cannot be attributed to DIS and/or DMS, and shows that the daytime functional impairment resulting from NRS alone is similar to that in patients with other insomnia symptoms. 23
  24. 24. 2 In Neuroscience Summary Pfizer continues to lead innovation with alpha-2-deltas PD-332,334 may offer improved treatment for GAD PD-200,390 offers unique potential to treat NRS, a key component of insomnia 24
  25. 25. Investing to Win in Alzheimer’s Disease Liam Ratcliffe, MD, PhD Senior Vice President and Development Head for Pfizer Neuroscience 25
  26. 26. Alzheimer’s is a Large and Growing Market By 2020… Epidemiology, Diagnosis and Treated Rates for the Major Markets An aging population will result in a ~30% increase Prevalence, Dx, and Tx Prevalence in 7 Major in prevalence Growth in 7 Major Markets Markets and China Improved tools will increase 27.1M 12.5M diagnosis rates 2 9.41M 18.3M 7.4 New therapies will boost 8 1.2 treatment rates 3.3 4.2 5.6 2.5 1.5 In U.S. alone, AD now 1.2 14.4 9 3.7 accounts for more than 3.4 $148 billion in direct 2008 2020 2008 2020 and indirect costs China JP Undiagnosed Diagnosed but Untreated with AD Drugs US EU5 Diagnosed and Treated with AD Drugs Increased diagnosis and treatment rates will nearly double the treated patient population Source; Leerink Swann analysis. *Extrapolated from UN census and prevalence data from 2008 US Alzheimer's facts and figures, Alzheimer’s association, # Internal Pfizer data, Source: Leerink Swann Analysis, Cowan 2008 TCO Report 26
  27. 27. Investment In Diagnostics Presents Further Commercial Opportunities in AD Emerging screening and diagnostic tools will allow for earlier treatment of the prodromal population Biochemical Markers Imaging Currently Diagnosed and Treated Patients Currently Undiagnosed Patients Prodromal Mild Mod. Severe Source: Leerink analysis; Yesavage J.A. Journal of Psychiatric Research 2002; 36:281-6; Graham J.E. Lancet 1997; 349:1793-6; Petersen R.C. Practice parameter: Early detection of dementia: Mild cognitive impairment; CME course material; Collie A. Australian and New Zealand Journal of Psychiatry 2002; 36:133-40 27
  28. 28. New Theories of AD Mechanisms Driving Current Research Aβ Antibodies and RAGE Antagonists Secretase Inhibitors Increase clearance of A decrease Amyloid Plaque Block production of A , decreasing buildup in the brain and reduce inflammation Amyloid Plaque buildup in the brain Tau Kinase Inhibitors PDE9i Block formation of tangles Synaptic stabilization in the brain Pfizer exploring multiple Alzheimer’s pathways and mechanisms 28
  29. 29. Pfizer Leading the Industry in Studying RAGE Pfizer is the only company studying RAGE in the clinic; currently in Phase 2 29
  30. 30. Two RAGE Studies Being Presented at ICAD Pre-clinical Data Phase 2 Study Schematic 30
  31. 31. Larger Phase 2 RAGE Study Now Underway 31
  32. 32. PF-04360365: Pfizer’s Anti-Amyloid Monoclonal Antibody m266 (LY 2062430) Targets AA 16 24; IgG1 PF 04360365 Targets AA 33 40; IgG2 a Bapineuzimab Targets AA 1 5; IgG1 N Terminus C Terminus Sources: Cowen and Company Dec 17, 2007; Siemers et al, International Conference on Alzheimer s disease; Madrid, Spain 2006; Natixis Bleichroeder; 32
  33. 33. Preclinical Monoclonal Antibody Data at ICAD Validates Proof of Concept 33
  34. 34. Phase 1 Monoclonal Antibody Study Now Underway 34
  35. 35. Pfizer Driving Science of PDE9 Inhibition Pfizer is the only company with a PDE-9 compound in the clinic; currently in Phase 1 35
  36. 36. AD Summary AD is an area with high unmet need resulting in a significant commercial opportunity A leading neuro-psychiatric cause of disability World population of 20 million+ patients growing, with approximately only one quarter currently being treated Pfizer is in a strong position to accelerate development of multiple compounds targeting various pathways to find new diagnostic and treatment solutions for AD Pfizer’s strategy: Accelerate our internal development portfolio Bolster our pipeline to include a larger, diversified portfolio 36
  37. 37. Investing to Win in Schizophrenia and Bipolar Disorder 37
  38. 38. Schizophrenia Symptom Domains Positive Affective Delusions Dysphoria Hallucinations Depression Unusual behavior Social and Occupational Dysfunction Negative Cognitive Flat affect Attention Social withdrawal Memory Emotional withdrawal Executive function Decision making Black DW et al. Introductory Textbook of Psychiatry. 2001;204-228. Siris SG. Schizophrenia. 1995;128-145. Harvey PD et al. Am J Psych. 2001;158:176-184. Stahl SM. Essential Psychopharmacology. 2000:99-133, 135-197, 365-399, 401-458. 38
  39. 39. Severe Mental Illness a Leading Cause of Global Disability with Significant Costs Schizophrenia – U.S. Bipolar Disorder – U.S. Total costs est. $63B (2002)2 Total economic costs est. $45B (1991)3 Medical care utilization: $22.7B Medical care utilization: $7B Indirect costs due to loss of productivity (mostly Indirect costs due to loss unemployment): $32.4B of productivity: $38B Schizophrenia is a leading cause of disability worldwide1 1Lopez AD, et al. eds. (2006) Global Burden of Disease & Risk Factors. NY: Oxford University Press/World Bank 2Wu et al 2005. 3 Wyatt et al. 1995 39
  40. 40. Management of Psychoses has Evolved; Significant Unmet Need Remains 1990 – 1990 – 2007 <1950 >1960 2008-2017 2007 Conventional Atypical Antipsychotics Sanitariums New MOAs Antipsychotics Surpass conventionals Highly Valued Clozapine 1st atypical Prototype antipsychotic Atypicals LOEs chlorpromazine Follow-up atypicals cleaner AE New mechanisms explored profiles, metabolic awareness ↑ Haloperidol (1988) Focus on cognitive deficits Expanded use in BP beyond mania Unmet need remains –ve symptom and cognition control CIAS unassessed formally, no drugs •Straight Jackets •Tranquilization and •Control of Positive and Negative •Improved Control of Control of Symptoms Symptom Domains •Shock Therapy Positive Symptoms •Acute and Maintenance Therapies •Novel Mechanisms to •Prefrontal •Treatments Associated for Bipolar Disorder Target Cognition Lobotomy With Significant Motor •Treatments Minimize Motor Disturbances Disorders Conventionals Atypicals Conventionals Mood Mood Stabilizers Mood Stabilizers Stabilizers Generic Atypicals Conventionals Atypicals New Entrants 40
  41. 41. Pfizer’s Symptom Focused Strategy Critical for Success Bipolar Disorder Schizophrenia Treatment Acute Adjunctive Adjunctive Bipolar Maintenance Resistant Mania Mania BP Depression Depression Gold Standard Mood Stabilizer Gold Standard Mood Stabilizer Monotherapy Monotherapy Treat acute mania Treat acute mania and prevent relapse for mania & depression and prevent relapse for mania & depression Bipolar Depression Bipolar Depression Monotherapy Monotherapy Treat acute depressive episode Treat acute depressive episode and prevent relapse into depression and prevent relapse into depression Antipsychosis Plus Antipsychosis Plus Schizophrenia Monotherapy Opportunity to Expand Schizophrenia Monotherapy Superior in one core domain (cognitive, affective) Superior in one core domain (cognitive, affective) BP depression and Maintenance and best-in-class safety/tolerability profile and best-in-class safety/tolerability profile Include Mania (base) Include Mania (base) Cognitive Symptoms Cognitive Symptoms Adjunctive to Antipsychotics Adjunctive to Antipsychotics Improvement in cognitive domains Improvement in cognitive domains Translates to improved patient functionality Translates to improved patient functionality 41
  42. 42. Schizophrenia Points of Intervention 5-HT2C agonists D2 antagonists increase striatal increase striatal activity activity by inhibiting by blocking dopamine dopamine cell firing (DA) inhibition Group II Glycine metabotropic Transporters glutamate (GlyT) receptor increase synaptic agonists levels of glycine (mGluR2/3) are involved in presynaptic inhibition PDE10A inhibitors directly activate the striatum to increase cortical feedback 42
  43. 43. Dopamine (D2) Partial Agonist – Phase 2 Study Underway 43
  44. 44. Glycine Transport Inhibitor Targets Cognition in Schizophrenia LTP 44
  45. 45. mGluR2/3 Agonist Now in Phase 1 Metabotropic Glutamate Receptors in the Synapse mGluR2/3 Receptors are Presynaptic and Directly Modulate Glutamate Release SnyderEM, Murphy MR. Schizophrenia Therapy: beyond atypical antipsychotics. Nat Rev Drug Discov 2008;7:6:471-1. 45
  46. 46. Schizophrenia & Bipolar Disorder Summary Like Alzheimer’s, Schizophrenia and Bipolar disorder remain areas of high unmet medical need Schizophrenia is a leading cause of disability worldwide Pfizer is strongly positioned with a rich portfolio of early stage compounds that target novel as well as unprecedented approaches Potential for breakthrough products that are paradigm shifting Pfizer’s strategy: Target syndromal control as well as key symptom domains, including cognition Accelerate internal development portfolio 46
  47. 47. Recap & Future Outlook Steve Romano, MD Vice President, Global Medical 47
  48. 48. Pfizer in Neuroscience – Key Takeaways Maximize value of marketed products Aricept, Geodon, Lyrica, Chantix 27 assets in Clinical Development Clinical Portfolio has almost doubled over the past 2 years Number of patient studies has also doubled over the past 2 years Keen focus on areas of value with heavy societal burden and high unmet patient need Alzheimer’s disease; Schizophrenia/Bipolar disorder Expansion of potential alpha-2-delta applications in GAD and NRS Pfizer committed to continued leadership 48
  49. 49. Q&A 49