Merck & Company, Inc. · NYSE:MRK
Merck & — Investor Day (May 2010)
165 slides from Merck &'s investor day presentation, May 11, 2010
Slide 1: R&D and Business Briefing
May 11, 2010 D R and Business Briefing
Slide 2: Alex Kelly, Vice President, Investor Relations
Alex Kelly Vice President, Investor Relations D R and Business Briefing
Slide 3: Forward-Looking Statement
Forward-Looking Statement This presentation contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ ma
Slide 4: No Duty to Update
No Duty to Update The information contained in the presentation set forth below was current as of May 11, 2010. While this presentation remains on the company's website the company assumes no duty to update the information to reflect subsequent developments. Consequently, the company will not update
Slide 5: Chairman and Chief Executive Officer Richard T. Clark
Chairman and Chief Executive Officer Richard T. Clark
Slide 6: Today's Merck Is Best Positioned
Today's Merck Is Best Positioned .... To meet evolving needs in a global healthcare environment .... To drive growth .... To maximize total shareholder return
Slide 7: Best Positioned and Delivering a Successful Merger
Accelerate Breakthrough Continued strong growth of key brands in first 2 quarters Built an outstanding leadership team Prioritized and advanced key R&D projects and launched new drugs Completed commercial integration of 16 of top 20 markets Announced plans to create a Merck and sanofi-aventis animal
Slide 8: Best Positioned and Off to a Fast Start
Best Positioned ... and Off to a Fast Start SINGULAIR Allergic Rhinitis/Asthma $2,425 11% ZETIA/VYTORIN Atherosclerosis $2,202 4% COZAAR/HYZAAR Hypertension $1,737 1% JANUVIA/JANUMET Diabetes $1,472 37% REMICADE Autoimmune Disorders $1,309 30% NASONEX Allergic Rhinitis $606 3% PROQUAD/MMRII/VARIVAX
Slide 9: Best Positioned for Success in Evolving Healthcare Environment
Best Positioned for Success in Evolving Healthcare Environment Healthcare reform Global pricing environment Major patent expirations Regulatory environment Follow-on biologics Emerging markets Preventive medicine
Slide 10: Industry Facing Major Patent Expirations
Industry Facing Major Patent Expirations 2009 2010 2011 2012 2013 2014 East 9.2 15.8 12.5 24.7 15.6 13.5 West 30.6 38.6 34.6 31.6 North 45.9 46.9 45 43.9 Merger strengthens patent position Major expirations COZAAR/HYZAAR 2010 SINGULAIR 2012 History of offsetting patent expirations with organic growt
Slide 11: Building a Strong Leadership Team
Building a Strong Leadership Team Help develop Merck's position on medical and product safety issues and their management. Provide input in establishing procedures to address product safety issues. Michael Rosenblatt, MD EVP & Chief Medical Officer Leverage Merck's consumer brands to capitalize on n
Slide 12: Building a Strong Leadership Team
Building a Strong Leadership Team Develop and execute strategy for Merck BioVentures, and manufacturing responsibility for Vaccines and Biologics Execute our plan to create a significant biologics presence for the new Merck. Rich Murray, PhD Senior Vice President, Biologics Research & Development De
Slide 13: Best Positioned R&D Pipeline
Best Positioned R&D Pipeline File 20111 Filed 2009 File 20101 File 20121 AIT Grass3 (US) BRIDION (US) Ezetimibe + Atorvastatin SAFLUTAN (US) Sitagliptin + Pioglitazone Telcagepant Vorapaxar BRINAVESS (EU) DULERA2 NOMAC/E2 (EU) SYCREST (EU) Boceprevir JANUMET XR (US) NOMAC/E2 (US) Ridaforolimus Sitag
Slide 14: Best Positioned to Successfully Launch New Products
Best Positioned to Successfully Launch New Products Track record of strong launches New commercial model focused on customers Strong local execution Primary care and specialty care capabilities Focused on driving growth
Slide 15: Best Positioned in Emerging Markets
Source: WHO; MSD. Women's Health Lack of access to contraception creates an enormous unmet medical need Diabetes 75%+ of worldwide diabetic population in Emerging Markets Vaccinations 28MM+ children per year do not receive basic vaccines Respiratory 300 million people currently suffer from asthma. M
Slide 16: Best Positioned to Do More Globally for Patients in Need
Best Positioned to Do More Globally for Patients in Need MSD Wellcome Trust Hilleman Labs, India MSD HIV/AIDS Partnership, China Rotavirus Infant Vaccination Program, Nicaragua Mectizan Donation Program UN Foundation Measles Initiative African Comprehensive HIV/AIDS Partnerships U.S. Patient Assista
Slide 17: Merck Consumer Care Positioned to Meet Growing Consumer Needs
Merck Consumer Care Positioned to Meet Growing Consumer Needs Diversification of portfolio Strong consumer brands lack patent expiry cliff Higher pipeline probability Rx to OTC switches Strong competitor with 2009 sales of $1.3 billion* Extends Merck's commitment to health and wellness Care for cons
Slide 18: Intervet/Schering-Plough Animal Health
Intervet/Schering-Plough Animal Health: Best Positioned to Be a Leader in Animal Health Solid business with proven track record of industry leading growth Leading industry position with $2.7 billion* in 2009 sales Broad balanced portfolio Strong R&D pipeline Experienced management team Planned JV wi
Slide 19: Today's Merck is Best Positioned to Be The Best Healthcare Company
Today's Merck is Best Positioned .... To Be The Best Healthcare Company
Slide 20: Peter S. Kim, President, Merck Research Laboratories
Peter S. Kim President, Merck Research Laboratories
Slide 21: Outline
Outline Merck's Pipeline Overview Portfolio Prioritization Biologics Commitment to Life Cycle Management Cardiovascular Research Late-Stage Pipeline Review Summary
Slide 22: Merck Pipeline April 30, 2010
Moved forward since last pipeline update Merck Pipeline1 April 30, 2010 Phase II Phase II Phase III Phase III Combination Products in Development7 Allergy, Immunotherapy SCH 9002372 HIV, vicriviroc (SCH 417690) Allergy, Grass Pollen SCH 6972432 Hepatitis C, boceprevir (SCH 503034) Atherosclerosis Ez
Slide 23: 2010 Merck Research & Development Highlights
2010 Merck Research & Development Highlights Filings 3 New Molecular Entities (NMEs) recently approved 4 NMEs under review Major market filings anticipated in 2010 5 NMEs and combination products 5 Products with new indications Ongoing late-stage programs in 2010 (US/EU) 21 NMEs and combinations in
Slide 24: Global Scientific Strategy and Worldwide Licensing
Global Scientific Strategy and Worldwide Licensing Gary Gilliland Senior Vice President & Franchise Head, Oncology Michael Mendelsohn Senior Vice President & Franchise Head, Cardiovascular Mirjam Mol-Arts Senior Vice President & Franchise Head, Women's Health & Endocrine Roger Pomerantz Senior Vice
Slide 25: Merck Pipeline Overview Roadmap
Merck Pipeline Overview Roadmap New Molecular Entities and Combination Products New Indications 2010 Anticipated Filings 5 Phase III Pipeline 16 Approvals 3 Under Review 4 5 2010 Anticipated Filings 4 Phase III New Indications 8 Approvals 4 Under Review January 2009 - April 2010 January 2009 - April
Slide 26: Recent Regulatory Approvals & Submissions: NMEs and Combinations
New Molecular Entities and Combination Products Recent Regulatory Approvals & Submissions (US/EU) Approvals1 January 2009 - April 2010 Under Review ELONVA Fertility, Controlled Ovarian Stimulation (EU 1/10) BRINAVESS3 Atrial Fibrillation (EU) SAPHRIS Schizophrenia, Bipolar I Disorder (US 8/09) DULER
Slide 27: SIMPONI: Human Monoclonal Antibody That Neutralizes TNF-alpha
SIMPONI: Human Monoclonal Antibody That Neutralizes Tumor Necrosis Factor (TNF) - alpha Once-monthly subcutaneous (SQ) injection Safety/tolerability Label consistent with anti-TNF class Core clinical development program GO-FORWARD RA patients previously treated with methotrexate GO-BEFORE RA patient
Slide 28: SAPHRIS Phase II/III Clinical Trials
SAPHRIS Phase II/III Clinical Trials 1Response = ^ 30% decrease from baseline in Positive And Negative Syndrome Score (total score) 2Pooled data from: Study 004: Placebo (n=60), Asenapine 5 mg BID (n=58), Risperidone 3 mg BID (n=56) Study 021: Placebo (n=93), Asenapine 5 mg BID (n=102), Asenapine 10
Slide 29: ELONVA (corifollitropin alfa)
ELONVA (corifollitropin alfa) New biological entity that binds to the Follicle-Stimulating Hormone (FSH) receptor Controlled ovarian stimulation in women undergoing assisted reproductive treatment One injection replaces 7 of FSH (FOLLISTIM) Status EU approval: January 2010 US filing anticipated: 201
Slide 30: NOMAC/E2 Combined Oral Contraceptive
NOMAC/E2 Combined Oral Contraceptive Monophasic combined oral contraceptive 17?-estradiol (E2) Estrogen identical to the one naturally present in a woman's body Nomegestrol acetate (NOMAC) Highly selective progestogen with a 46-hour half-life Suppresses ovulation with a stable bleeding pattern Statu
Slide 31: DULERA: Mometasone Furoate/Formoterol
Significant bronchodilation Fast onset of action Effective control of inflammation True 24 hour Protection DULERA1: Mometasone Furoate/Formoterol (MF/F) MFF Combining Two Best in Class Molecules Formoterol Mometasone Furoate MDI Under review for Asthma (US/EU) BID dosing (100 ?g/10 ?g - 400 ?g/10 ?g
Slide 32: DULERA: Combining Two Molecules to Treat Asthma
DULERA: Combining Two Molecules to Treat Asthma Uncontrolled by Steroids Alone Phase III efficacy studies in moderate to severe asthmatics Adults and pediatrics All primary and co-primary endpoints met per protocol Time-to-first severe asthma exacerbation Change in FEV11 Generally well tolerated No
Slide 33: Merck Pipeline Overview Roadmap
Merck Pipeline Overview Roadmap New Molecular Entities and Combination Products New Indications 2010 Anticipated Filings 5 Phase III Pipeline 16 Approvals 3 Under Review 4 5 2010 Anticipated Filings 3 Phase III New Indications 8 Approvals 4 Under Review January 2009 - April 2010 January 2009 - April
Slide 34: Merck Late-Stage Pipeline: NMEs and Combination Products
New Molecular Entities and Combination Products Merck Late-Stage Pipeline April 30, 2010 (US/EU)1 2010 Anticipated Filings Phase III Programs (Anticipated Filing Date) Phase III Programs (Anticipated Filing Date) Phase III Programs (Anticipated Filing Date) NOMAC/E2 Contraception (US) SCH 6972432,3
Slide 35: Merck Pipeline Overview Roadmap
Merck Pipeline Overview Roadmap New Molecular Entities and Combination Products New Indications 2010 Anticipated Filings 5 Phase III Pipeline 16 Approvals 3 Under Review 4 5 2010 Anticipated Filings 3 Phase III New Indications 8 Approvals 4 Under Review January 2009 - April 2010 January 2009 - April
Slide 36: New Indications - Recent Regulatory Approvals & Submissions
New Indications - Recent Regulatory Approvals & Submissions (US/EU) as of April 30, 20101 Approvals January 2009 - April 2010 Approvals January 2009 - April 2010 Under Review GARDASIL Adult women (up to 45 years of age) cervical cancer and genital warts (EU 7/09) Supplement for boys and men (US 10/0
Slide 37: Merck Pipeline Overview Roadmap
Merck Pipeline Overview Roadmap New Molecular Entities and Combination Products New Indications 2010 Anticipated Filings 5 Phase III Pipeline 16 Approvals 3 Under Review 4 5 2010 Anticipated Filings 3 Phase III New Indications 8 Approvals 4 Under Review January 2009 - April 2010 January 2009 - April
Slide 38: New Indications/Formulations Late-Stage Pipeline
New Indications/Formulations Merck Late-Stage Pipeline April 30, 2010 (US/EU) 2010 Anticipated New Indications Filings 2010 Anticipated New Indications Filings Phase III New Indications (anticipated filing date) Phase III New Indications (anticipated filing date) ARCOXIA Acute Pain (EU) TEMODAR Dose
Slide 39: Zostavax Trial Results: 50 to 59 Year-Olds
Zostavax Trial Results: 50 to 59 Year-Olds Approximately 1 million cases of Herpes Zoster occur annually in the US1 The incidence of Herpes Zoster doubles between the 40 to 49 and 50 to 59 year-old age groups Incidence estimates for 50 to 59 year-olds ~ 5/1,000 per year Results: Vaccine efficacy for
Slide 40: Japan - Recent Regulatory Approvals & Submissions
Approvals - New Molecular Entities and Combinations January 2009 - April 2010 Approvals New Indications January 2009 - April 2010 Under Review Under Review Anticipated Filings (2010) Anticipated Filings (2010) BRIDION Neuromuscular Blockade Reversal ASMANEX (mometasone furoate inhalation powder) Ast
Slide 41: Outline
Outline Merck's Pipeline Overview Portfolio Prioritization Biologics Commitment to Life Cycle Management Cardiovascular Research Late-Stage Pipeline Review Summary
Slide 42: Overview: Portfolio Prioritization Process
Overview: Portfolio Prioritization Process November December February January Portfolio Review #1 December Immediate Action Review Meeting Schering-Plough Leadership Portfolio Debrief Final Recommended Portfolio Phase I - LCM1 Priorities/Resources Meeting January/February Portfolio Review #2 Early J
Slide 43: Prioritization of the Phase II and III Portfolio
Prioritization of the Phase II and III Portfolio 0 5 10 15 20 25 30 35 Phase IIA Phase III Phase IIB Stop On Hold Proceed Number of Programs Merck's Clinical Pipeline Has Contributions From Both Legacy Companies (55% MRK; 45% SGP)
Slide 44: Merck Phase II Pipeline
New Molecular Entities Merck Phase II Pipeline April 30, 2010 2010 Phase II 2010 Phase II 2010 Phase II Allergy, Immunotherapy1 SCH 900237 Contraception Medicated IUS (SCH 900342) Parkinson's Disease Preladenant (SCH 420814) Asthma MK-0476C Diabetes MK-3577 Pediatric Vaccine V419 Atrial Fibrillation
Slide 45: Outline
Outline Merck's Pipeline Overview Portfolio Prioritization Biologics Commitment to Life Cycle Management Cardiovascular Research Late-Stage Pipeline Review Summary
Slide 46: Merck Biologics
Merck Biologics Health Care Reform bill Innovative products: 12 years of data exclusivity Biosimilars: Pathway for FDA approval Merck's Biologics pipeline Novel biologics Marketed products: REMICADE, SIMPONI, FOLLISTIM, ELONVA, PEGINTRON 5 candidates in clinical development Biosimilars 2 candidates
Slide 47: Biologics Clinical Development Pipeline
Biologics Clinical Development Pipeline April 30, 2010 Novel Biologics Biosimilars - MBV1 SCH-900105 (alpha HGF)/oncology (HGF = hepatocyte growth factor) MK-4214 G-CSF (G-CSF = granulocyte colony stimulating factor) MK-0646 IGF-1R/oncology MK-6302 G-CSF (pegylated) SCH 900222 (anti-IL-23)/immunolog
Slide 48: Merck's Overall Biologics R&D Strategy
Merck's Overall Biologics R&D Strategy Technical Difficulty A Balanced Biologics Portfolio Biosimilars Accelerated development pathway Highly similar to innovator Merck BioVentures BioBetters Improve key traits of an established therapeutic protein Clinical differentiation vs the original product No
Slide 49: Outline
Outline Merck's Pipeline Overview Portfolio Prioritization Biologics Commitment to Life Cycle Management Cardiovascular Research Late-Stage Pipeline Review Summary
Slide 50: ZETIA/VYTORIN Life Cycle Management
ZETIA/VYTORIN Life Cycle Management Long-Term Safety & Efficacy Studies 1st Phase 2nd Phase 3rd Phase Ongoing/recently completed Core Phase III Program Monotherapy Co-administration with statins Special populations Homozygous Familial Hypercholesterolemia Sitosterolemia Add-on to fenofibrate, ER nia
Slide 51: ZETIA/VYTORIN Ongoing Outcomes Study: IMPROVE-IT
ZETIA/VYTORIN Ongoing Outcomes Study: IMPROVE-IT CV outcomes of patients with acute coronary syndrome 18,000 patients; >17,000 currently randomized Ezetimibe/simvastatin 10/40 mg (titrated up to 80 mg) Simvastatin 40 mg (titrated up to 80 mg) Anticipated study completion: 2013 Data Safety Monitoring
Slide 52: ZETIA/VYTORIN Ongoing Outcomes Study: SHARP
ZETIA/VYTORIN Ongoing Outcomes Study: SHARP Benefit of statins in patients with chronic kidney disease not established Two trials in patients on hemodialysis failed to demonstrate CV benefit of statin treatment 4D with atorvastatin1 AURORA with rosuvastatin2 SHARP: evaluate ezetimibe/simvastatin 10/
Slide 53: JANUVIA/JANUMET Life Cycle Management
Long-Term Safety & Efficacy Studies JANUVIA/JANUMET Life Cycle Management 1st Phase 2nd Phase 3rd Phase Ongoing/recently completed Core Phase III Program Monotherapy Combination therapy with metformin and with PPAR? Renal failure dosing Add-on to metformin vs sulfonylurea JANUMET Program Add-on to s
Slide 54: Sitagliptin vs Glimepiride Added to Metformin
Body Weight (kg) Change From Baseline (LS Mean 95% CI) ? = -2.0 kg; p<0.001 - -0.8 1.2 - -1.5 - -1.0 - -0.5 0.0 0.5 1.0 1.5 Body Weight Sitagliptin 100 mg Glimepiride 1 - 6 mg All Patients as Treated Week 30 ? =-15.0%; p<0.001 Percent of Patients 7.0 22 0 5 10 15 20 25 Hypoglycemia All Patients as T
Slide 55: JANUVIA Safety and Tolerability: A Pooled Analysis
JANUVIA Safety and Tolerability: A Pooled Analysis Pooled analysis: double-blind, controlled studies Up to 2 years in duration >10,000 patients Incidence rates of adverse events were generally similar in patients treated with Sitagliptin vs not treated with Sitagliptin1 Retrospective, pooled safety
Slide 56: Life Cycle Management: REMICADE
Long-Term Safety & Efficacy Studies Life Cycle Management: REMICADE 1st Phase 2nd Phase 3rd Phase Ongoing Crohn's Disease Rheumatoid Arthritis Signs & Symptoms Psoriasis Ulcerative Colitis Moderate/severe Surgical prevention Crohn's Disease 2nd-line treatment Pediatric Crohn's Disease Ulcerative Col
Slide 57: REMICADE vs Azathioprine in Crohn's Disease
REMICADE - Greater Steroid-Free Remission and Mucosal Healing Compared With Azathioprine (AZA) in Treatment of Crohn's Disease Second-line treatment of moderate to severe Crohn's Disease patients Primary endpoint: steroid- free remission at week 26 Results: 47 out of 107 patients taking REMICADE + A
Slide 58: ISENTRESS Life Cycle Management
Long-Term Safety & Efficacy Studies ISENTRESS Life Cycle Management 1st Phase 2nd Phase 3rd Phase 4th Phase Core Phase III Program Treatment- Experienced HIV Patients Once Daily 800 mg Program Compact Regimens Nucleoside Reverse Transcriptase Inhibitor- sparing Pediatric Program Collaborative Studie
Slide 59: GARDASIL: Life Cycle Management Plan
Long-Term Safety & Efficacy Studies 1st Phase 2nd Phase 3rd Phase Core Phase III Program Cervical Cancer (HPV types 16 and 18) Genital warts (HPV types 6 & 11) Vulvar & vaginal cancer (HPV types 16 & 18) Male Program External Genital Lesions (HPV types 6 and 11) Male Program Concomitant Use Repevax,
Slide 60: Luciano Rossetti, SVP, Global Scientific Strategy
Luciano Rossetti Senior Vice President, Global Scientific Strategy, Merck Research Laboratories
Slide 61: Merck Maintains a Strong Commitment to Cardiovascular Disease Research
Global cardiovascular deaths are expected to rise to ~31% of global mortality by 20101 Hypertension, thrombosis and dyslipidemia remain the largest opportunities ~90,000 patients currently enrolled in Merck-sponsored cardiovascular outcomes trials Merck Maintains a Strong Commitment to Cardiovascula
Slide 62: Cardiovascular - Outline
Cardiovascular - Outline Thrombosis - Atrial Fibrillation Vorapaxar (Phase III) Betrixaban (Phase IIB) BRINAVESS (under review) Ischemia Reperfusion Acadesine (Phase III) Atherosclerosis - Dyslipidemia TREDAPTIVE (Phase III, US) Anacetrapib (Phase III)
Slide 63: Formation of a Thrombus
>» Formation of a Thrombus Damaged Vessel TF (Tissue Factor) Intrinsic Pathway one Extrinsic Pathway ‘TF (Tissue Factor) ee vir Xa Vila + TF 2} xia x 4 Factor Xa Betrixaban Thrombin prothrombin Fibrinogen asin
Slide 64: Formation of a Thrombus
Formation of a Thrombus PAR-1: Protease Activated Receptor 1
Slide 65: Differentiating Thrombosis Treatments
Differentiating Thrombosis Treatments Controlling Platelets Controlling Coagulation Vorapaxar is an antiplatelet agent Betrixaban is an anticoagulant agent Oral Antiplatelets (e.g., Aspirin, Plavix, Vorapaxar) Target the platelet and not the coagulation cascade Anticoagulants (Coumadin, Heparins, Fa
Slide 66: Vorapaxar: Unique Mechanism of Action as a PAR-1 Antagonist
Does not interfere with platelet collagen signaling Has no role in factor- dependent coagulation Prevents occlusive thrombus formation while not increasing the risk of bleeding Anticipated filing 2011 Vorapaxar: Unique Mechanism of Action as a PAR-1 Thrombin Receptor Antagonist
Slide 67: Vorapaxar: TRA-PCI Phase II Study
Vorapaxar: TRA-PCI Phase II Study *All patients on Standard of Care (aspirin, clopidogrel, anticoagulant) MACE: Major Adverse Cardiovascular Events; p-value relative to placebo Becker et al, Lancet, Mar 2009, Vol 373 4% 0% 2% 1% 3% 5% 3.3% All Doses n=422 Placebo n=151 10mg n=129 20mg n=120 40mg n=1
Slide 68: Vorapaxar: Dose Selection
Vorapaxar: Dose Selection Basic Principles No incremental increase in major bleeding at any dose tested1,2 Rapid onset of inhibition of platelet aggregation Inhibition of TRAP- mediated Platelet Aggregation Percent of Patients achieving platelet inhibition at 28 Days* Percent of Patients achieving p
Slide 69: Vorapaxar Acute Coronary Syndrome Study
Vorapaxar Acute Coronary Syndrome Study Enrollment >90% Complete Placebo n = 6125 TRA 40 mg Loading Dose 2.5 mg QD n = 6125 Placebo n =13,500 TRA 2.5 mg QD n = 13.500 Loading dose: 40 mg Vorapaxar vs placebo followed by 2.5 mg QD vs placebo Event driven for both primary and key secondary endpoint Mi
Slide 70: Vorapaxar Secondary Prevention
Vorapaxar Secondary Prevention Enrollment Completed November 2009 Placebo n = 6125 TRA 40 mg Loading Dose 2.5 mg QD n = 6125 Placebo n =13,500 TRA 2.5 mg QD n = 13.500 Placebo vs 2.5 mg Vorapaxar QD Event driven for both primary and key secondary endpoint Minimum one year follow-up Interim analysis
Slide 71: Atrial Fibrillation Is Growing in Prevalence
Atrial Fibrillation Is Growing in Prevalence Total prevalence of Atrial Fibrillation (AF) will reach nearly 10 million in major markets by 2016 Associated with 2-fold increase in mortality and 5-fold increase in stroke Source: Decision Resources 2008 Total Prevalence: 2006-2016 Millions 0 2,000 4,00
Slide 72: Betrixaban: EXPLORE Xa Trial
Betrixaban: EXPLORE Xa Trial to Investigate Bleeding Profile in Patients With Atrial Fibrillation Significantly less bleeding for Betrixaban 40 mg vs warfarin Number of strokes were within the range expected for warfarin Low peak-to-trough ratio; half-life suitable for once-daily dosing Anticipate n
Slide 73: BRINAVESS (Vernakalant IV)
BRINAVESS (Vernakalant IV): Novel Multi-ion Channel Blocker With Preferential Action on the Atrium Need for rapid, well-tolerated alternative for pharmacological cardioversion Active comparator study shows superiority of BRINAVESS over amiodarone IV for rapid cardioversion (within 90 min) of recent
Slide 74: Cardiovascular - Outline
Cardiovascular - Outline Thrombosis - Atrial Fibrillation Vorapaxar (Phase III) Betrixaban (Phase IIB) BRINAVESS (under review) Ischemia Reperfusion Acadesine (Phase III) Atherosclerosis - Dyslipidemia TREDAPTIVE (Phase III, US) Anacetrapib (Phase III)
Slide 75: Acadesine: Adenosine Regulating Agent
Acadesine: Adenosine Regulating Agent Ischemia/Reperfusion injury is a serious unmet medical need post-Coronary Artery Bypass Graft (CABG) High complication rate despite procedural improvements No approved therapies RED-CABG: ongoing single pivotal Phase III outcome study Acadesine IV (0.1 mg/kg/min
Slide 76: Cardiovascular - Outline
Cardiovascular - Outline Thrombosis - Atrial Fibrillation Vorapaxar (Phase III) Betrixaban (Phase IIB) BRINAVESS (under review) Ischemia Reperfusion Acadesine (Phase III) Atherosclerosis - Dyslipidemia TREDAPTIVE (Phase III, US) Anacetrapib (Phase III)
Slide 77: Merck Atherosclerosis Strategy Targeting Residual Risk
Merck Atherosclerosis Strategy Targeting Residual Risk Although statins are effective in reducing cardiovascular risk, many patients remain at risk for cardiovascular events Merck is developing drugs to be used in combination with statins to further reduce cardiovascular risk Merck portfolio include
Slide 78: Niacin: Cardiovascular Benefits and Tolerability
Niacin Has Demonstrated Cardiovascular Benefits, but Use May Be Limited by Tolerability In imaging and outcome studies1,2, administration of niacin at doses >1.5 g/day reduces atherosclerosis and cardiovascular risk However, use in clinical practice may be limited by tolerability; major issue is flu
Slide 79: TREDAPTIVE Program: Effects on Multiple Lipoproteins
TREDAPTIVE Program: Positive Effects on Multiple Lipoproteins In addition to high LDL-C levels, guidelines identify patients with low HDL-C and high non-HDL-C at increased coronary heart disease risk1,2,3,4 Recent genetic evidence links Lp(a) to cardiovascular events5 TREDAPTIVE Merck's extended-rel
Slide 80: HPS2-THRIVE Cardiovascular Outcomes Study
HPS2-THRIVE: On-going cardiovascular outcomes study to support US registration To assess the effect of TREDAPTIVE (2g) vs placebo on the risk of major vascular events in high-risk patients on simvastatin Conducted by Oxford University Clinical Trials Service Unit 25,000 patients randomized External
Slide 81: Anacetrapib (MK-0859): Strong Biologic Rationale
Anacetrapib (MK-0859): Strong Biologic Rationale Selective, potent, reversible CETP inhibitor Does not covalently bind CETP No effect on blood pressure, serum electrolytes or aldosterone 1Tall, A. et al. Published online in ATVB, April 2010 (presented at the International Symposium on Atherosclerosi
Slide 82: Anacetrapib: Effect on LDL-C and HDL-C
Anacetrapib: Effect on LDL-C and HDL-C Degree of CETP inhibition is related to effects on LDL-C and HDL-C Treatment with Anacetrapib (10, 40, 150, and 300 mg QD) led to dose- dependent changes in LDL-C and HDL-C Bloomfield et al, Am Heart J, 2009, Volume 157 - -50 - -40 - -30 - -20 - -10 0 0 50 100
Slide 83: Anacetrapib: Status of Clinical Program
Anacetrapib: Status of Clinical Program Phase III DEFINE study ongoing; enrollment completed 20091 1,623 patients with CHD or CHD risk-equivalent Anacetrapib 100 mg once daily vs placebo (all patients on a statin) 18-month study; recently extended for additional 2 years Independent Data Safety Monit
Slide 84: Merck Is Poised to Lead in Cardiovascular Research
Merck Is Poised to Lead in Cardiovascular Research With 6 molecules in late-stage clinical development ~90,000 patients enrolled in outcomes trials In thrombosis with therapies that offer improved profiles In atherosclerosis with a wide range of options for LDL lowering as well as HDL raising
Slide 85: Peter S. Kim, President, Merck Research Laboratories
President, Merck Research Laboratories Peter S. Kim
Slide 86: Pipeline - Anticipated Filing Dates, Major Market
New Molecular Entities and Combination Products Merck Pipeline - Anticipated Filing Dates, Major Market 2012 2010 2011 >2012 (select) Acadesine AIT-Ragweed (US) ELONVA (US) MK-0524A (US) MK-0524B MK-4305 Odanacatib V503 Under Review BRINAVESS (EU) DULERA1 NOMAC/E2 (EU) SYCREST (EU) Anticipated Bocep
Slide 87: Boceprevir - Oral HCV Protease Inhibitor
Boceprevir - potent, oral HCV protease inhibitor SPRINT-11: Phase II in treatment naive patients Add-on to standard of care: peg-interferon/ribavirin (P/R) Positive Sustained Virological Response (SVR)3 results Incidence of skin related adverse experiences comparable to placebo Increased incidence o
Slide 88: Boceprevir Improved SVR in Null Responders
Boceprevir Improved SVR in Null Responders Phase II Naive (SPRINT-1) Post-hoc Analysis Historically, Null responders = <2log10 decrease in HCV-RNA at Treatment (Tx) week 12 with P/R IDEAL STUDY1 Decrease in HCV-RNA at Tx week 4 and 12 were highly correlated (p<0.0001) Patients with <1 log10 decrease
Slide 89: Opportunity for Response Guided Therapy
Opportunity for Response Guided Therapy Rapid Virological Response (RVR) ~ Two-thirds of Treatment-Naive Patients in SPRINT-1 achieved RVR RVR= undetectable HCV-RNA at Boceprevir treatment week 4 (following a 4 week P/R lead in)1 Time after Boceprevir dosing to first negative HCV-RNA 1Kwo, et al. Pr
Slide 90: RVR is a Strong Predictor of Response
* 4 week P/R lead in # p=NS ** p<0.004 28 weeks of therapy 48 weeks of therapy Time* after boceprevir dosing to first negative HCV-RNA 82 21 0 94# 79** 0 ^4 weeks 4 to 12 weeks >12 weeks % Patients Achieving SVR 0 60 80 100 20 40 RVR is a Strong Predicator of Response SPRINT-1 Post-hoc Analysis1 Pat
Slide 91: Response Guided Therapy in Treatment Naive Patients
Response Guided Therapy (RGT) in Treatment Naive Patients: Potential For 28 Week Treatment SPRINT-2: ~1080 treatment naive gentoype 1 patients P = peg-interferon 1.5 ^g/kg R = ribavirin 800-1400 mg per day, based on weight Phase III Week 28 Week 48 Week 72 P/R Placebo + P/R P/R Wk 8 HCV RNA (-) (+)
Slide 92: Boceprevir Ongoing Clinical Program
Of the 290 responders (SVR) followed for at least 2 years, there have been no confirmed relapses Co-Infection Treatment Naive HCV/HIV N=~100 EPO study (Anemia Management) N=660 RESPOND-2* (Treatment Failure) SPRINT-2* (Treatment Naive) PEG2a* (Treatment Failure) N=198 Initial Registration *Fully Enr
Slide 93: Ridaforolimus: Oral mTOR Inhibitor
Ridaforolimus: Oral mTOR Inhibitor mTOR signaling is activated in essentially all tumor types plays a central role in cell growth Agreement with Ariad was renegotiated (May 2010); Merck now has full, exclusive license to Ridaforolimus Phase III Program ongoing Soft-Tissue Sarcoma Regimen: 5 days out
Slide 94: Pipeline - Anticipated Filing Dates, Major Market
New Molecular Entities and Combination Products Merck Pipeline - Anticipated Filing Dates, Major Market Acadesine AIT-Ragweed (US) ELONVA (US) MK-0524A (US) MK-0524B MK-4305 Odanacatib V503 Under Review BRINAVESS (EU) DULERA1 NOMAC/E2 (EU) SYCREST (EU) Anticipated Boceprevir JANUMET XR (US) MK-0431D
Slide 95: BRIDION (sugammadex)
BRIDION (sugammadex): Selective Neuromuscular Relaxant Binding Agent First-in-class First major innovation in anesthesiology reversal in over 20 years Rapidly reverses neuromuscular block induced by rocuronium or vecuronium Provides optimal surgical conditions and predictably reversed 95% of patient
Slide 96: Status of BRIDION (sugammadex)
Approved in 47 countries including Japan Additional clinical studies Hypersensitivity Assessment in normal volunteers with results in 2010 Anticoagulation Transient increase of ~ 20% in aPTT (activated Partial Thromboplastin Time) Assessment in clinical studies planned for 2010 Anticipated US resubm
Slide 97: Telcagepant: CGRP Receptor Antagonist
First new mechanism in 20 years for migraine non-vasoconstrictive Phase III pivotal studies met all primary endpoints1-3 Long term acute migraine safety study (up to 18 months) complete (n~650 on treatment) Migraine prophylaxis trial stopped in 2009 Liver enzyme elevations in some patients One addit
Slide 98: Telcagepant: Cardiovascular Safety Evaluation
Telcagepant: Cardiovascular Safety Evaluation in Individuals With Cardiovascular Disease Treadmill exercise-induced angina model Population: individuals with reproducible exercise-induced angina Doses: (Telcagepant vs placebo) 600mg (n=46) 900mg (n=14) For reference, Telcagepant clinical dose = 140m
Slide 99: SAFLUTAN (Tafluprost)
Glaucoma leads to optic nerve damage from increased intraocular pressure Preservative-free Tafluprost provides a new option for patients with glaucoma who cannot tolerate preservative-containing ophthalmics Phase III noninferiority study: preservative-free Tafluprost vs preservative-free timolol EU:
Slide 100: Allergy Immunotherapy Tablets (AIT)
Allergy Immunotherapy Tablets (AIT) A fast-dissolving, once-daily, sublingual tablet Disease modification after repeated administration of allergens as a result of immune tolerance US clinical program status Grass tablet Primary endpoint was met in adult and pediatric subjects with a history of gras
Slide 101: Pipeline - Anticipated Filing Dates, Major Market
New Molecular Entities and Combination Products Merck Pipeline - Anticipated Filing Dates, Major Market Acadesine AIT-Ragweed (US) ELONVA (US) MK-0524A (US) MK-0524B MK-4305 Odanacatib V503 Under Review BRINAVESS (EU) DULERA1 NOMAC/E2 (EU) SYCREST (EU) Anticipated Boceprevir JANUMET XR (US) MK-0431D
Slide 102: MK-4305: Orexin Receptor Antagonist
MK-4305: Orexin Receptor Antagonist A New Approach for the Treatment of Insomnia Image: Adapted from Sakurai, Nature Reviews Neuroscience March 2007, Volume 8, pp 171-181 Orexin Neurons Most treatments for insomnia have focused on the GABA system May affect many processes in addition to sleep (e.g.
Slide 103: MK-4305 Phase IIb Study in Primary Insomnia
MK-4305: Orexin Receptor Antagonist Phase IIb Study in Patients With Primary Insomnia Cross over study design MK-4305 vs placebo MK-4305 interim results1 n=217 Baseline sleep efficiency, nights 1 and 28 (co-primary endpoints) MK-4305 was superior vs placebo (p-value <0.005) Sleep induction and maint
Slide 104: Preladenant: Adenosine 2A Receptor Antagonist
Preladenant: Adenosine 2A Receptor Antagonist for Parkinson's Disease In Parkinson's Disease (PD), dopaminergic tone is lost, leading to an increased inhibition of motor movement Available drugs all work by increasing dopaminergic tone Adenosine 2A (A2A) receptors regulate neurons in the basal gangl
Slide 105: Preladenant Efficacy in Moderate-to-Severe PD
Preladenant Demonstrated Efficacy in Moderate-to-Severe PD Patients Receiving Dopaminergic Therapy Phase IIb Showed efficacy in both on and off time with no proportional increases in dyskinesias Generally well tolerated Phase III Anticipated start: 2010 Adjunctive and monotherapy Change From Baselin
Slide 106: Dalotuzumab for Metastatic Colorectal Cancer
Dalotuzumab for Metastatic Colorectal Cancer IGF-1R is a proximal regulator of the PI3K signaling pathway Over expression of IGF-1R in cancers may correlate with progression Dalotuzumab is an Anti-IGF-1R monoclonal antibody Treatment of metastatic colorectal cancer Alternate treatment arm (standard
Slide 107: Ridaforolimus/Dalotuzumab for Luminal B Breast Cancer
Ridaforolimus/Dalotuzumab Monoclonal Antibody Combination for Luminal B Breast Cancer PI3 Kinase Pathway is up-regulated in Luminal B breast cancer 25% of breast cancers Patients have a poor prognosis Tumor cells bypass mTOR inhibition via a feedback loop that activates IGF-1R signaling Preclinicall
Slide 108: MK-3415A for C. difficile Infection
C. difficile infection (CDI) is the most important cause of healthcare-associated diarrhea High recurrence rate (>20%) MK-3415A is a combination of monoclonal antibodies against two pathogenic toxins (A and B) Phase IIb Results1 Treatments: MK-3415A or placebo Added on top of Standard-of-care (metro
Slide 109: V710: Staphylococcus aureus Vaccine
V710: Staphylococcus aureus Vaccine S. aureus can cause serious disease with infections that range from localized skin infections to septic shock Methicillin-resistant S. aureus (MRSA) is a major cause of hospital- acquired staphylococcal diseases1 Increases in community-associated MRSA infections c
Slide 110: Odanacatib for the Treatment of Osteoporosis
Odanacatib for the Treatment of Osteoporosis Cathepsin K is responsible for bone matrix degradation Odanacatib is a selective and reversible inhibitor of Cathepsin K Dose: 50 mg once-weekly With or without food No unique postural requirements Cathepsin K inhibition decreases bone resorption similarl
Slide 111: Odanacatib Phase IIb Study 3-Year Data
Odanacatib Phase IIb Study 3-Year Data 0.42 N=14 ^ Least Square Mean 7.85 N=17 Lumbar Spine BMD (gm/cm2) % Change From Baseline (Mean +-SE) 0 12 24 36 Month - -2 - -1 0 1 2 3 4 5 6 7 8 9 Placebo 50 mg Odanacatib Once Weekly 1Eisman, J. et al. Presented at American Society of Bone and Mineral Researc
Slide 112: Increases in Cortical Thickness in Pre-Clinical Model
ODN baseline2 ODN 18 months2 Increases in Cortical Thickness in the Distal Radius in a Pre-Clinical Model1 ‡ 0 3 6 9 12 15 18 Month 0.5 0.55 0.6 0.65 0.7 0.75 0.8 0.85 Cortical Thickness (mm) ‡ ALN ODN PBO ODN: 2 mg/kg daily (approximates human clinical exposure - efficacy dose) ALN: 30 µg/kg/wk PBO
Slide 113: Odanacatib Clinical Program
4-Year Phase IIb data to be presented in the Fall 2010 Odanacatib Phase III Fracture outcomes trial ongoing Fully enrolled: >16,000 postmenopausal women with osteoporosis Anticipated filing: 2012 Odanacatib Clinical Program
Slide 114: Merck Pipeline April 30, 2010
Moved forward since last pipeline update Merck Pipeline1 April 30, 2010 Phase II Phase II Phase III Phase III Combination Products in Development7 Allergy, Immunotherapy SCH 9002372 HIV, vicriviroc (SCH 417690) Allergy, Grass Pollen SCH 6972432 Hepatitis C, boceprevir (SCH 503034) Atherosclerosis Ez
Slide 115: Global Human Health Overview: Kenneth C. Frazier
Global Human Health Overview Kenneth C. Frazier President, Merck & Co., Inc
Slide 116: Today's Merck: A New Leader in Global Healthcare
Today's Merck: A New Leader in Global Healthcare Our broader portfolio of market-leading medicines and vaccines Our greater geographic footprint in key markets Our strong late-stage pipeline and the excellence of our research organization Our customer-centered commercial model that enables rapid int
Slide 117: A Diverse Portfolio and Global Presence
A Diverse Portfolio and Global Presence 1Q 2010 Pharma & Vaccines Revenue1 1Q 2010 Total Revenue United States EUCan Emerging Markets Japan 42 32 17 8 Bone, Resp, Immun & Derm Mature Brands Cardiovascular Infectious Disease Vaccines Diabetes Oncology Women's Health Neuro & Ophth Other Animal Health
Slide 118: New Commercial Model: Drives Strong Performance
New Commercial Model: Drives Strong Performance Merck has launched a new commercial model globally: Model is flexible with execution based on local market dynamics and customer input Focus on customer value and trust Multi-channel approaches and new technologies Open and robust dialogue with scienti
Slide 119: New Commercial Model Enables Rapid Integration
New Commercial Model Enables Rapid Integration of Our Commercial Organization Jan China Korea Puerto Rico U.S. Feb Australia Brazil Canada Turkey March Belgium Mexico April Spain Venezuela May Germany* Portugal Switzerland UK France Italy Japan Netherlands Planned 16 of Our Top 20 markets have alrea
Slide 120: Portfolio of Options in Key Therapeutic Areas
CV and Diabetes Infectious Diseases Respiratory/ Bone/ Imm/Derm Women's Health Neuro/ Ophthalmology Oncology Vaccines Mature Brands Best Positioned to Offer Customers a Portfolio of Options in Key Therapeutic Areas
Slide 121: Expanded Respiratory Portfolio Enables Franchise Maximization
LTRA 12009 Supplemental Combined Non-GAAP sales 2The trade name DULERA is under regulatory review in the U.S. 3Co-promotion agreement for Canada and certain European countries; distribution agreement in UK Long-acting ^2-agonist Intra-Nasal Corticosteroid Inhaled Corticosteroids Short-acting ^2-agon
Slide 122: Best Positioned to Lead in Cardiovascular Disease
Best Positioned to Lead in Cardiovascular Disease Revenue Source: Datamonitor In-line Products Pipeline Products Market (US, EU, Japan) Cardiac Arrhythmia Thrombosis Cardiac Reperfusion Dyslipidemia Hypertension $17B (Anti-thrombotics) $500K - $1B $36B $26B Anacetrapib (Phase III) Acadesine (Phase I
Slide 123: ZETIA and VYTORIN
ZETIA and VYTORIN High-risk patient, further from LDL-C goal LDL-C treatment gap, need for goal attainment Help high-risk patients get to, and stay at, LDL-C goal ZETIA in Japan ZETIA and VYTORIN in Core EUCan Markets (Value unit: JPYMM) 0 2000 4000 6000 8000 10000 1Q08 2Q08 3Q08 4Q08 1Q09 2Q09 3Q09
Slide 124: JANUVIA and JANUMET: Continue Strong Global Performance
JANUVIA and JANUMET: Continue Strong Global Performance Broadening market leadership: Strong launch underway in Japan Sustained double-digit sales growth in all regions and major markets, including US and EU Emerging Markets already contribute > $200 million Positioned for continued success: Opportu
Slide 125: Early Signals Through Integration Are Encouraging
Early Signals Through Integration Are Encouraging Broader portfolio of pharmaceuticals and vaccines Eight of our Top Ten products growing through integration Greater geographic diversity Nine of our Top Ten markets growing - seven growing double digits More efficient and effective customer- centric
Slide 126: Global Human Health Overview: Adam Schechter
Global Human Health Overview Adam Schechter President, Global Human Health
Slide 127: Powerful Co-positioning Drives Growth in Spring Allergy Season
Powerful Co-positioning Drives Growth During the Spring Allergy Season Co-positioning strategy and resources launched in January - - 100 200 300 400 500 600 700 800 900 1,000 1/1/2010 1/8/2010 1/15/2010 1/22/2010 1/29/2010 2/5/2010 2/12/2010 2/19/2010 2/26/2010 3/5/2010 3/12/2010 3/19/2010 3/26/2010
Slide 128: ISENTRESS: Continues to Grow
Physician and patient perceptions positive, with strong differentiation on tolerability Excellent efficacy and tolerability profile with data extending through 3 years in 2010 ISENTRESS: Continues to Grow 0 5 10 15 20 25 30 35 40 45 50 Jan-09 Feb-09 Mar-09 Apr-09 May-09 Jun-09 Jul-09 Aug-09 Sep-09 O
Slide 129: New Commercial Model Led to Reduction in US Sales Force
New Commercial Model Led to a Significant Reduction in US Sales Force Merck Schering-Plough Customer Facing Organization 0 2,000 4,000 6,000 8,000 10,000 12,000 14,000 2007 2008 2009 2010
Slide 130: Demonstrating Increased Value and Trust With Customers
Demonstrating Increased Value and Trust With Customers Ind. Avg Merck "The most trusted and valued company in helping me help my patients" Source: 1Q09 Baseline Trust & Value Survey We started 2009 ranked 4th in an undifferentiated group of top healthcare companies...
Slide 131: Merck is the Leading Company in Trust and Value
Merck is the Leading Company in Terms of Trust and Value Ind. Avg Merck "The most trusted and valued company in helping me help my patients" Source: 2009 Year End Trust & Value Survey ... and finished 2009 with a lead over all healthcare companies in the competitive set.
Slide 132: New Commercial Model Drives Positive Business Performance
The New Commercial Model Drives Positive Business Performance Higher SINGULAIR share among physicians who rank Merck #1 on Trust & Value 15 20 25 30 Aug-07 Nov-07 Feb-08 May-08 Aug-08 Nov-08 Feb-09 May-09 TRx Share (%) Selected as Top (n=2,820) Not Selected as Top (n=12,460) Geographies with higher
Slide 133: Higher Employee Engagement and Better Performance
New Commercial Model Leads to Higher Employee Engagement and Better Performance Employee Engagement Trust & Value Performance High Trust & Value scores and high levels of employee engagement resulted in improved business performance
Slide 134: Global Human Health Overview: Bruno Strigini
Global Human Health Overview Bruno Strigini President EUCAN Region I, Global Human Health
Slide 135: Shifting Power of Key Stakeholders Transforms Business Model
Shifting Power of Key Stakeholders Is Transforming Our Current Business Model Sales Rep Government Payors Patients Illustrative Scenario Rx Decision HCP Medical Affairs Market Access We are implementing a new commercial model based on customer centricity ... Standardize brands but customize and pers
Slide 136: EUCan Outperforms the Market Since Merger Announcement
EUCan Outperforms the Market Since Merger Announcement Source: IMS for all except, Inside Health in Germany (Adjusted for Trans Border Sales) and GERS for France Strong in-market performance across countries, with Evolution Index for Core 5 + Canada of 103.2 (MAT Jan/Feb 2010, IMS) Core 5 + Canada U
Slide 137: New Commercial Model in Europe: SINGULAIR in UK
Implementation of New Commercial Model in Europe Drives Significant Business Results SINGULAIR in UK 0 1,000 2,000 3,000 4,000 5,000 6,000 Jan-07 Mar-07 May-07 Jul-07 Sep-07 Nov-07 Jan-08 Mar-08 May-08 Jul-08 Sep-08 Nov-08 Jan-09 Mar-09 May-09 Jul-09 Sep-09 Nov-09 Jan-10 SINGULAIR MAT Absolute Cash
Slide 138: Outperforming the Competition: Germany
Source: IMS, GESDAT data Leveraging Strong Clinical Profile to Outperform the Competition: Germany % Market Share Note: Sitagliptin Family includes Velmetia and Xelevia (clones of JANUVIA/JANUMET that are out-licensed in Germany) Apr-09 9-May Jun-09 Jul-09 Aug-09 Sep-09 Oct-10 Nov-09 Dec-10 Jan-10 F
Slide 139: New Commercial Model in Europe: MSD Italy
Implementation of New Commercial Model in Europe Drives Significant Business Results Changing profile of MSD Italy's income statement Sales (€/.Mln) % of Sales 0 100 200 300 400 500 600 700 800 2007 2008 2009 Sales Direct Selling % Sales Promotion % Sales Operating Income % Sales 0
Slide 140: REMICADE: Customer-Focused Approach Delivers Growth
REMICADE: A Customer-Focused Approach Delivers Growth From All Indications $1.6B $2.1B $2.3B 2008 and 2009 splits by Merck estimate 10% 16% 10% 13% 23% 8% 0 ..5 1.0 1.5 2.0 2.5 2007 2008 2009 Psoriasis Ulcerative Colitis Crohn's Disease Psoriatic Arthritis Ankylosing Spondylitis Rheumatoid Arthritis
Slide 141: Co-Positioning Maximizes Combined Franchise Market Penetration
Monthly SIMPONI: Advanced SC anti-TNF; Best patient experience First choice SC anti-TNF Only REMICADE offers the power and speed of IV anti-TNF RA: First choice for the RPP SpAs: First choice for pts w/history of EAMs REMICADE offers the power and speed of IV anti-TNF For rapidly progressing disease
Slide 142: SIMPONI Is Exceeding Recent Launch Benchmarks
SIMPONI Is Exceeding Recent Launch Benchmarks Without Cannibalizing REMICADE *Source: Canadian 'SIMPONI for Me' Patient Support Program, 12/2009; n=343 SIMPONI Source of Business* SIMPONI Source of Switch (non-naive) CANADA (SIMPONI) CANADA (Cimzia) GERMANY (SIMPONI) GERMANY (Cimzia) 0 0.5 1.0 1.5 2
Slide 143: Global Human Health Overview: Julie Gerberding, MD
Global Human Health Overview Julie Gerberding, MD President, Merck Vaccines
Slide 144: Merck Vaccine Strategy
Merck Vaccine Strategy Strengthen leadership in vaccines through broad portfolio Develop new vaccines to prevent medically important infectious diseases in global markets Expand use of recently launched vaccines Globalize business and expand access to current and new products Ensure robust, redundan
Slide 145: Broad Portfolio of Vaccines
Broad Portfolio of Vaccines US Vaccination Schedule Pediatric Vaccines: Merck offers 8 of the 11 recommended vaccines Adult Vaccines: Merck offers 9 of the 10 recommended vaccines Haemophilus influenzae type B Hepatitis A Hepatitis A Hepatitis B Hepatitis B Human Papillomavirus Human Papillomavirus
Slide 146: Significant Investment to Ensure Robust Supply
Significant Investment to Ensure Robust, Reliable, and Redundant Supply Carlow, Ireland Durham, NC MMR-II and varicella zoster virus-based vaccines Vaccines and biologics
Slide 147: Opportunity to Reduce Burden of Herpes Zoster
Significant Opportunity Remains to Reduce Burden of Herpes Zoster Among Older Adults † Population Division of the Department of Economic and Social Affairs of the United Nations Secretariat. ‡ The number of HZ cases was calculated by applying the Hope-Simpson HZ incidence rates to the 2005 U.S. popu
Slide 148: Sustaining Leadership in HPV Vaccines
Sustaining Leadership in HPV Vaccines V503 Will offer protection against ~87% of cancer-causing HPV types Anticipated filing 2012 GARDASIL Most approved indications of available HPV vaccines Only HPV vaccine indicated for males Significant opportunity remains to reach primary cohort and to complete
Slide 149: Globalize Business and Expand Access
Globalize Business and Expand Access Significant opportunity for growth in developed markets and Emerging Markets Emerging Markets: Merck vaccine portfolio ideally suited to Emerging Market needs 80% of the global vaccine preventable disease burden is in Emerging Markets Expand current portfolio thr
Slide 150: Global Human Health Overview: Stefan Oschmann
Global Human Health Overview Stefan Oschmann President, Emerging Markets
Slide 151: Merck's Goal: Be as Strong in Emerging Markets as Globally
Rank Company Rank Company 1 1 2 2 3 3 4 4 5 5 6 6 7 7 8 8 9 9 10 10 Source: IMS Health, MIDAS, MAT Dec 2009 *Includes Asia Pacific, Latin America, Eastern Europe, Middle East & Africa Global Emerging Markets* Merck's Goal is To Be as Strong in the Emerging Markets as We Are Globally
Slide 152: Merck's Strategy for Emerging Market Success
Merck's Strategy for Emerging Market Success Drive Emerging Market growth through broad portfolio of pharmaceuticals, vaccines, follow-on biologics and consumer health products Expanding access to our in-line and mature products Maximizing the value of our innovative pipeline Complementing Merck's p
Slide 153: Unmet Medical Need in Emerging Markets
SOURCE: WHO; MSD Women's Health Lack of access to contraceptives creates an enormous unmet medical need Diabetes 75%+ of worldwide diabetic population in Emerging Markets Vaccinations 28MM+ children per year do not receive basic vaccines Respiratory 300MM people currently suffer from asthma. Most as
Slide 154: Resources Reallocated to Emerging Markets
Resources Have Been Reallocated From Developed Markets to Emerging Markets Merck Schering-Plough China Net Increase ~90% 0 500 1000 1500 2000 2500 3000 3500 2007 2008 2009 2010 Customer Facing Organization
Slide 155: Merck Ranks Second in Latin America
Merck Ranks Second in Latin America and Has Six of the Top 20 Products Across the Region *Only Retail Sales Source: IMS - Dec/2009 Ethical Pharmaceutical Market* Leading Products MAT Dec/2009 Source: IMS - Dec/2009 Top 12 Leading Health Companies - Retail Market Competitive Comparison - Market Share
Slide 156: Maximizing the Value of Innovation: JANUVIA in Asia Pacific
Maximizing the Value of Innovation in Emerging Markets JANUVIA in Asia Pacific AP Oral Anti-Diabetic Market, $ Market Share Market success based upon: Commercially and socially responsible pricing: Success in reimbursed (e.g., Korea) and self-pay (e.g., India) markets A commitment to physician and p
Slide 157: Merck's Plan for Emerging Market Leadership
Merck's Plan for Emerging Market Leadership Drive Emerging Market growth through broad portfolio of new, in-line and mature products Complement Merck's portfolio with branded generics and other products through local and regional partnerships or acquisitions Increase focus on lifecycle management to
Slide 158: Global Human Health Overview: Kenneth C. Frazier
Global Human Health Overview Kenneth C. Frazier President, Merck & Co., Inc
Slide 159: Broad In-line Portfolio and Promising Late Stage Pipeline
.... and a Promising Late Stage Pipeline1 CV and Diabetes Infectious Diseases Respiratory/ Bone/ Imm/Derm Women's Health Neuro/ Ophthalmology Oncology Phase III Candidates TREDAPTIVE Niacin/laropiprant/ simvastatin Anacetrapib Vorapaxar DPP-4/TZD Acadesine (IRI) AIT (grass pollen, ragweed) Odanacati
Slide 160: Major Launches Under Way to Drive Growth
ASMANEX Asthma Launching in Japan BRIDION Anesthesia reversal Launching in ~ 30 countries ex-US ELONVA Fertility Launching in EU JANUVIA Type 2 diabetes Launching in Japan REMERON Depression Launching in Japan SAFLUTAN Glaucoma Launching in EU SAPHRIS Schizophrenia and bipolar I disorder Launching i
Slide 161: Opportunities for Launches in Japan
Combined Portfolio and Pipeline Creates Many Opportunities for Launches in Japan1 Approvals - New Molecular Entities and Combinations January 2009 - April 2010 Approvals New Indications January 2009 - April 2010 Under Review Under Review Anticipated Filings (2010) Anticipated Filings (2010) BRIDION
Slide 162: Commercial Opportunity With Odanacatib
Anticipated Filing in 2012 Significant Potential Commercial Opportunity With Odanacatib Large disease burden; under- diagnosed and undertreated An aging population will drive increased prevalence of osteoporosis 190MM globally by 2014 Emerging Markets represent a significant growth opportunity Unmet
Slide 163: Boceprevir: Unmet Medical Need in Hepatitis C
Boceprevir: Opportunity to Address a Huge Unmet Medical Need in Hepatitis C 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 Year HCV sales ($m) JAPAN 5EU US Anticipated Filing in 2010 Source: Datamonitor 2008 5EU:France, Germany, Italy, Spain
Slide 164: Vorapaxar's Addressable Market
Acute Coronary Syndrome (ACS) Heart muscle is not getting enough blood flow Heart attack with positive biomarkers indicating necrosis Most severe heart attack with total blockage Post- NSTEMI or STEMI event Post MI Myocardial Infarction Post- obstruction within a blood vessel supplying blood to the
Slide 165: Merck's Priority is Delivering Top-line Organic Growth
Merck's Priority is Delivering Top-line Organic Growth Merck is focused on driving growth based on the following elements: Driving strong global growth from JANUVIA/JANUMET, REMICADE, SIMPONI, ISENTRESS, ZETIA/VYTORIN Merck's Emerging Market business is anticipated to grow faster than underlying Eme