bristol myerd squibb bristol-myers squibb at the j.p. morgan 27th annual healthcare conference
TRANSCRIPT
JP Morgan JP Morgan Healthcare ConferenceHealthcare Conference
Elliott Elliott SigalSigal, M.D., Ph.D., M.D., Ph.D.Executive Vice President,Executive Vice President,
Chief Scientific Officer and President, R&DChief Scientific Officer and President, R&D
January 14, 2009January 14, 2009
2BMS Confidential and Proprietary Information
During this meeting, we will make statements about the During this meeting, we will make statements about the CompanyCompany’’s future plans and prospects, including statements s future plans and prospects, including statements about our financial position, business strategy, research pipeliabout our financial position, business strategy, research pipeline ne concerning product development and product potential, that concerning product development and product potential, that constitute forwardconstitute forward--looking statements for purposes of the safe looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reformharbor provisions under the Private Securities Litigation Reform Act of 1995.Act of 1995.Actual results may differ materially from those indicated by theActual results may differ materially from those indicated by these se forwardforward--looking statements as a result of various important looking statements as a result of various important factors, including those discussed in the companyfactors, including those discussed in the company’’s most recent s most recent annual report on Form 10annual report on Form 10--K, periodic reports on Form 10K, periodic reports on Form 10--Q and Q and current reports on Form 8current reports on Form 8--K. These documents are available from K. These documents are available from the SEC, the Bristolthe SEC, the Bristol--Myers Squibb website or from BristolMyers Squibb website or from Bristol--Myers Myers Squibb Investor Relations.Squibb Investor Relations.In addition, any forwardIn addition, any forward--looking statements represent our looking statements represent our estimates only as of today and should not be relied upon as estimates only as of today and should not be relied upon as representing our estimates as of any subsequent date. While we representing our estimates as of any subsequent date. While we may elect to update forwardmay elect to update forward--looking statements at some point in looking statements at some point in the future, we specifically disclaim any obligation to do so, evthe future, we specifically disclaim any obligation to do so, even en if our estimates change. if our estimates change.
3BMS Confidential and Proprietary Information
Pharmaceuticals Bring Significant Pharmaceuticals Bring Significant Benefits to PatientsBenefits to Patients
Since the midSince the mid--1990s, when researchers developed a 1990s, when researchers developed a new wave of medicines to treat HIV/AIDS, the U.S. death new wave of medicines to treat HIV/AIDS, the U.S. death rate from AIDS has dropped about 70% rate from AIDS has dropped about 70% (Lancet, 2003)(Lancet, 2003)Since 1971, the number of cancer medicines has tripled. Since 1971, the number of cancer medicines has tripled. These new drugs account for 50These new drugs account for 50--60% of the increase in 60% of the increase in sixsix--year cancer survival rates since 1975 (year cancer survival rates since 1975 (National National Bureau of Economic Research, 2004Bureau of Economic Research, 2004))From 1993From 1993--2003, death rates from cardiovascular 2003, death rates from cardiovascular disease in general and coronary heart disease have disease in general and coronary heart disease have declined roughly 22% and 30%, respectively declined roughly 22% and 30%, respectively (Circulation, 2006)(Circulation, 2006)New medicines generated 40% of the twoNew medicines generated 40% of the two--year gain in year gain in life expectancy achieved in 52 countries between 1986 life expectancy achieved in 52 countries between 1986 and 2000 (PhRMA, quoting research from and 2000 (PhRMA, quoting research from Health AffairsHealth Affairs))
4BMS Confidential and Proprietary Information
PharmaPharma Industry Must Adapt to Changing Industry Must Adapt to Changing External EnvironmentExternal Environment
Traditional “vertically integrated”model is risky, costly and unsustainable
True innovation must demonstrate True innovation must demonstrate clinical clinical and and economic value with economic value with more comprehensive assessments more comprehensive assessments of benefit/riskof benefit/risk
Partnering for both innovationand commercial success is keyto remaining competitive –and may be an advantage
Productivity and costeffectiveness must bea core competency
Accelerating patent expirations / Accelerating patent expirations / challengeschallenges
Greater Greater regulatory / clinical regulatory / clinical requirements and declining R&D requirements and declining R&D productivityproductivity
Decreased access to physicians Decreased access to physicians
Increasing roleIncreasing role of payers in of payers in access, pricing and prescribingaccess, pricing and prescribing
Heightened political focus on Heightened political focus on healthcare / pharmaceuticalshealthcare / pharmaceuticals
Access to capital for smaller Access to capital for smaller companiescompanies
External Challenges Implications for Pharma
5BMS Confidential and Proprietary Information
Best of PharmaBest of Biotech
SelectiveSelective IntegrationIntegration
•• Internal capabilities Internal capabilities complemented with external complemented with external innovation sourcesinnovation sources
•• CoCo--development anddevelopment and coco--commercializationcommercialization
•• Flexible global supply chainFlexible global supply chain
•• Targeted approach to Targeted approach to geographies and customersgeographies and customers
•• Innovative sales andInnovative sales and marketing approachesmarketing approaches
Continuous Continuous ImprovementImprovement
•• Strong continuous Strong continuous improvement capabilities improvement capabilities
•• Simplified processesSimplified processes
•• Enhanced efficiency and Enhanced efficiency and effectivenesseffectiveness
•• Aligned infrastructure to Aligned infrastructure to support growthsupport growth
Innovative Innovative PortfolioPortfolio
•• Serious unmet medical Serious unmet medical needs in specialty and needs in specialty and high prevalence disease high prevalence disease
•• Multiple therapeutic Multiple therapeutic modalities (e.g. small & modalities (e.g. small & large molecules) large molecules)
•• Greater value for payersGreater value for payers
Next Generation BioPharma
Agile, Entrepreneurial & Accountable CultureAgile, Entrepreneurial & Accountable Culture
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Strong Execution in 2008 Towards TheStrong Execution in 2008 Towards The NextNext--Generation Generation BioPharmaBioPharma Model Model
Significant changes in BMS business portfolio Significant changes in BMS business portfolio
Strong operating performance Strong operating performance
Improved overall financial position Improved overall financial position
Important progress against String of Pearls Important progress against String of Pearls
Increased focus on longer term sustainability Increased focus on longer term sustainability
7BMS Confidential and Proprietary Information
Best of PharmaBest of Biotech
SelectiveSelective IntegrationIntegration
•• Internal capabilities Internal capabilities complemented with external complemented with external innovation sourcesinnovation sources
•• CoCo--development anddevelopment and coco--commercializationcommercialization
•• Flexible global supply chainFlexible global supply chain
•• Targeted approach to Targeted approach to geographies and customersgeographies and customers
•• Innovative sales andInnovative sales and marketing approachesmarketing approaches
Continuous Continuous ImprovementImprovement
•• Strong continuous Strong continuous improvement capabilities improvement capabilities
•• Simplified processesSimplified processes
•• Enhanced efficiency and Enhanced efficiency and effectivenesseffectiveness
•• Aligned infrastructure to Aligned infrastructure to support growthsupport growth
Innovative Innovative PortfolioPortfolio
•• Serious unmet medical Serious unmet medical needs in specialty and needs in specialty and high prevalence disease high prevalence disease
•• Multiple therapeutic Multiple therapeutic modalities (e.g. small & modalities (e.g. small & large molecules) large molecules)
•• Greater value for payersGreater value for payers
Next Generation BioPharma
Agile, Entrepreneurial & Accountable CultureAgile, Entrepreneurial & Accountable Culture
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Unique Organization Enables Execution Unique Organization Enables Execution of String of Pearls Strategyof String of Pearls Strategy
Consolidated all transactional groups into a Consolidated all transactional groups into a unique Strategic Transactions Group unique Strategic Transactions Group
Streamlined governance process and due Streamlined governance process and due diligence for all transactionsdiligence for all transactions
Enabled rapid decisionEnabled rapid decision--making, flexibility and making, flexibility and involvement of the most senior level executivesinvolvement of the most senior level executives
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String of Pearls Focuses on Key Disease AreasString of Pearls Focuses on Key Disease Areas
PriorityPriority FocusFocus
AdditionalAdditional AreasAreas ConsideredConsidered
SecondarySecondaryAreasAreas
Expand Into
Neuropathic Pain
Build Major Metabolic Capability
Leverage Psychiatric Franchise
Migrate Into Cognition
Build Alzheimer's
Portfolio
Expand Immuno- science
Sustain HIV Franchise
Expand Hematologic Malignancy
Migrate Into Cardiology
Adjacencies
Build on Solid Tumor Capability
Jumpstart HCV
KosanKosan IsisIsisExelixisExelixis
KAIKAI
Solid TumorSolid TumorBrivanibBrivanib,,
antianti--CD137, EVRI,CD137, EVRI, AR, Epo Folate,AR, Epo Folate,
IGF, Met IGF, Met KinaseKinase, Cdc7, Cdc7KosanKosan
AdnexusAdnexus MedarexMedarexExelixisExelixis
HematologicHematologic MalignancyMalignancy
SprycelSprycel
PDLPDL
KosanKosan
ExelixisExelixis
String of Pearls Strengthen Key Disease AreasString of Pearls Strengthen Key Disease Areas
Hepatitis CHepatitis CHCV NS5A inhibitor,HCV NS5A inhibitor,
HCV target #2,HCV target #2,HCV target #3HCV target #3
CardiologyCardiologyApixabanApixaban
Alzheimer'sAlzheimer'sGamma Gamma
SecretaseSecretase
ZymoZymo-- GeneticsGenetics
11BMS Confidential and Proprietary Information
String of Pearls Multiple Integration String of Pearls Multiple Integration Approaches: ExamplesApproaches: Examples
Full Integration ApproachFull Integration ApproachFacilities and personnel consolidatedFacilities and personnel consolidatedAll assets developed internally by BMSAll assets developed internally by BMSTarget company fully absorbedTarget company fully absorbed
Hybrid Integration Approach Hybrid Integration Approach Biologic (Biologic (adnectinadnectin) discovery through proof of ) discovery through proof of confidence runs independently confidence runs independently Clinical development post proof of confidence by BMSClinical development post proof of confidence by BMS
Product Approach Product Approach InIn--licensing of single or multiple products licensing of single or multiple products Shared development & commercialization or Shared development & commercialization or internal BMS development & commercializationinternal BMS development & commercialization
12BMS Confidential and Proprietary Information
Best of PharmaBest of Biotech
SelectiveSelective IntegrationIntegration
•• Internal capabilities Internal capabilities complemented with external complemented with external innovation sourcesinnovation sources
•• CoCo--development anddevelopment and coco--commercializationcommercialization
•• Flexible global supply chainFlexible global supply chain
•• Targeted approach to Targeted approach to geographies and customersgeographies and customers
•• Innovative sales andInnovative sales and marketing approachesmarketing approaches
Continuous Continuous ImprovementImprovement
•• Strong continuous Strong continuous improvement capabilities improvement capabilities
•• Simplified processesSimplified processes
•• Enhanced efficiency and Enhanced efficiency and effectivenesseffectiveness
•• Aligned infrastructure to Aligned infrastructure to support growthsupport growth
Innovative Innovative PortfolioPortfolio
•• Serious unmet medical Serious unmet medical needs in specialty and needs in specialty and high prevalence disease high prevalence disease
•• Multiple therapeutic Multiple therapeutic modalities (e.g. small & modalities (e.g. small & large molecules) large molecules)
•• Greater value for payersGreater value for payers
Next Generation BioPharma
Agile, Entrepreneurial & Accountable CultureAgile, Entrepreneurial & Accountable Culture
13BMS Confidential and Proprietary Information
2009 Projected Key Data Flow & Events2009 Projected Key Data Flow & Events
OnglyzaOnglyza (Saxagliptin)(Saxagliptin)
Mechanism of action study: ADA, JuneMechanism of action study: ADA, JunePhase III longPhase III long--term safety & efficacy: ADA, June or EASD, Septterm safety & efficacy: ADA, June or EASD, SeptUS & EU approval decisionsUS & EU approval decisionsUS submission for onceUS submission for once--daily, fixeddaily, fixed--dose combination of dose combination of saxagliptin + saxagliptin + metforminmetformin
DapagliflozinDapagliflozin Ph Ph IIbIIb highly insulin refractory study highly insulin refractory study --009: ADA, June009: ADA, JuneInitial Ph III data: ADA, June or EASD, SeptInitial Ph III data: ADA, June or EASD, Sept
ErbituxErbitux US regulatory decisions for head & neck cancer and lung cancerUS regulatory decisions for head & neck cancer and lung cancer
IpilimumabIpilimumab Additional survival data availableAdditional survival data available
AbilifyAbilify US submission for autismUS submission for autism
PlavixPlavix CURRENT dataCURRENT data
ApixabanApixabanInitiation of Ph III acute coronary syndromeInitiation of Ph III acute coronary syndromePh III EU DVT prevention data: ISTH, JulyPh III EU DVT prevention data: ISTH, JulyPh III DVT prevention data: ASH, DecemberPh III DVT prevention data: ASH, December
OrenciaOrencia Ph III subcutaneous safety data: ACR, OctoberPh III subcutaneous safety data: ACR, OctoberPh II psoriatic arthritis data: ACR, OctoberPh II psoriatic arthritis data: ACR, October
BelataceptBelatacept Ph III data: American Transplant Congress, MayPh III data: American Transplant Congress, MayUS & EU submissionsUS & EU submissions
Note: Dependent on data availability, acceptance of medical meeting submissions or health authority actionsAs of January 2009
14BMS Confidential and Proprietary Information
Belatacept: High Unmet Medical Need in Belatacept: High Unmet Medical Need in Renal TransplantationRenal Transplantation
LongLong--term patient and graft survival are limitedterm patient and graft survival are limitedOne year survival rates >90%One year survival rates >90%Five year survival rates 66% Five year survival rates 66% –– 79% 79%
Causes of death and graft loss Causes of death and graft loss Cardiovascular disease Cardiovascular disease Chronic allograft nephropathy (CAN) Chronic allograft nephropathy (CAN)
Calcineurin Inhibitors (CNI) are associated with Calcineurin Inhibitors (CNI) are associated with longlong--term complicationsterm complications
Nephrotoxicity Nephrotoxicity Hypertension, diabetes, Hypertension, diabetes, hyperlipidemiahyperlipidemia
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Belatacept Phase III ProgramBelatacept Phase III Program
ThreeThree--year clinical trials against Cyclosporine Ayear clinical trials against Cyclosporine A
Study Study --027 (BENEFIT027 (BENEFIT--EXT): Extended criteria, EXT): Extended criteria, deceased donors (N = 540)deceased donors (N = 540)
Study Study --008 (BENEFIT): Standard criteria, living or 008 (BENEFIT): Standard criteria, living or deceased donors (N = 660)deceased donors (N = 660)
Primary endpoints (12 months) focused on longPrimary endpoints (12 months) focused on long--term term outcomesoutcomes
Renal function: emerging as key predictor ofRenal function: emerging as key predictor oflonglong--term graft survivalterm graft survival
Subject and graft survival Subject and graft survival
Acute rejection: coAcute rejection: co--primary endpoint in Study primary endpoint in Study --008008
16BMS Confidential and Proprietary Information
Hepatitis C Virus (HCV): Unmet Medical NeedHepatitis C Virus (HCV): Unmet Medical Need
200 million infections worldwide, 5 million in the US200 million infections worldwide, 5 million in the US
Major cause of cirrhosis and Major cause of cirrhosis and hepatocellularhepatocellularcarcinoma leading to ~10,000 deaths per year carcinoma leading to ~10,000 deaths per year
Current standard of careCurrent standard of care–– 4040--50% sustained response rate50% sustained response rate–– 2020--50% incidence of side effects often leading to 50% incidence of side effects often leading to
reduction in dosage or discontinuation reduction in dosage or discontinuation
Death rate predicted to increase dramatically over Death rate predicted to increase dramatically over the next 20 years in the absence of effective therapythe next 20 years in the absence of effective therapy
17BMS Confidential and Proprietary Information
MultiMulti--pronged Strategy for HCV Treatmentpronged Strategy for HCV Treatment
Multiple approachesMultiple approachesSmall molecule Small molecule antiviralsantivirals as addas add--on to interferonon to interferonSmall molecule antiviral combinations to replace Small molecule antiviral combinations to replace interferoninterferonNext generation interferon with fewer side effects to Next generation interferon with fewer side effects to replace current interferonreplace current interferon
Current HCV PipelineCurrent HCV PipelineInterferon lambda from Interferon lambda from ZymoGeneticsZymoGenetics showing showing antiviral activity without typical interferon side effectsantiviral activity without typical interferon side effectsThree mechanistically distinct, internal compounds in Three mechanistically distinct, internal compounds in the clinicthe clinic
18BMS Confidential and Proprietary Information
HCV NS5A: Mean Change in HCV RNA HCV NS5A: Mean Change in HCV RNA from Baseline Following a Single Dosefrom Baseline Following a Single Dose
Proof-of-concept study, AASLD, November 2008
-4
-3
-2
-1
0
0 6 16 24 36 48 72 144Time (hours)
log 1
0H
CV
RN
A (I
U/m
L)
BMS-790052 10mg n=5BMS-790052 100mg n=5
Placebo n=2BMS-790052 1mg n=6
19BMS Confidential and Proprietary Information
AlzheimerAlzheimer’’s Disease s Disease
Unmet Medical NeedUnmet Medical NeedAffects over 24 million people worldwideAffects over 24 million people worldwidePrevalence expected to quadruple by 2050 due to aging Prevalence expected to quadruple by 2050 due to aging population and lack of diseasepopulation and lack of disease--modifying agentsmodifying agentsCurrent therapies offer transient symptomatic benefitCurrent therapies offer transient symptomatic benefit
Current Approach: Target the two hallmarks ofCurrent Approach: Target the two hallmarks of AlzheimerAlzheimer’’s Diseases Disease
AmyloidAmyloid plaques: gamma plaques: gamma secretasesecretase inhibitorsinhibitorsTangles: microtubule stabilizers (internal and Kosan)Tangles: microtubule stabilizers (internal and Kosan)
20BMS Confidential and Proprietary Information
Gamma Gamma SecretaseSecretase: Dose: Dose--dependent dependent Reductions in Human CSF AReductions in Human CSF Aββ40/4240/42
BMS Study CN156-002, ICAD, July 2008
0 50 100 1500
25
50
75
100
125
150 A A ββ
4040
A A ββ
4242
Dose, mg
CSF
Aβ
(% b
asel
ine)
21BMS Confidential and Proprietary Information
Continuing Our Strong Track RecordContinuing Our Strong Track Record of Successof Success
20052005 20062006 20072007
Otsuka America Pharmaceutical, Inc.
ImClone Systems Incorporated
HIV / AIDS
Schizophrenia, Depression
Cancer
Hepatitis B
Rheumatoid Arthritis
HIV / AIDS
Cancer
Cancer
20032003 20042004 20082008 20092009
Onglyza (saxagliptin)*
belatacept**
Solid Organ Translplant
Diabetes
* NDA under review**Projected submission in 2009
JP Morgan JP Morgan Healthcare ConferenceHealthcare Conference
Elliott Elliott SigalSigal, M.D., Ph.D., M.D., Ph.D.Executive Vice President,Executive Vice President,
Chief Scientific Officer and President, R&DChief Scientific Officer and President, R&D
January 14, 2009January 14, 2009