Cowen Health Care Conference · Broad IBroad I--O portfolioO portfolio NOT FOR PRODUCT PROMOTIONAL...
Transcript of Cowen Health Care Conference · Broad IBroad I--O portfolioO portfolio NOT FOR PRODUCT PROMOTIONAL...
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CowenCowenCowenCowenHealth Care ConferenceHealth Care Conference
Brian Daniels, M.D.Brian Daniels, M.D.Brian Daniels, M.D.Brian Daniels, M.D.Senior Vice President, Senior Vice President,
Global Development & Medical AffairsGlobal Development & Medical AffairsGlobal Development & Medical AffairsGlobal Development & Medical Affairs
March 4, 2014March 4, 2014
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ForwardForward--Looking InformationLooking InformationggDuring this meeting, we will make statements about the During this meeting, we will make statements about the Company’s future plans and prospects that constitute forwardCompany’s future plans and prospects that constitute forward--yylooking statements for purposes of the safe harbor provisions looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated as a Actual results may differ materially from those indicated as a result of various important factors including those discussedresult of various important factors including those discussedresult of various important factors, including those discussed result of various important factors, including those discussed in the company’s most recent annual report on Form 10in the company’s most recent annual report on Form 10--K and K and reports on Form 10reports on Form 10--Q and Form 8Q and Form 8--K. These documents are K. These documents are available from the SEC, the Bristolavailable from the SEC, the Bristol--Myers Squibb website or Myers Squibb website or from Bristolfrom Bristol--Myers Squibb Investor Relations.Myers 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 y y py y prepresenting our estimates as of any subsequent date. While representing our estimates as of any subsequent date. While we may elect to update forwardwe may elect to update forward--looking statements at some looking statements at some point in the future, we specifically disclaim any obligation to do point in the future, we specifically disclaim any obligation to do so even if our estimates changeso even if our estimates change
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so, even if our estimates change.so, even if our estimates change.
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Evolution of BioPharma StrategyEvolution of BioPharma StrategyEvolution of BioPharma StrategyEvolution of BioPharma Strategy
Specialty CareSpecialty CareBioPharmaBioPharma
InnovativeInnovativePharmaceuticalsPharmaceuticals
2007 2013
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BMS R&D FocusBMS R&D Focus
I O l
Disease Area FocusDisease Area Focus Drug PlatformsDrug Platforms
Immuno-Oncology
Oncology
Immunoscience
CardiovascularSmall Small MoleculesMolecules BiologicsBiologics
Virology
Fibrotic Diseases
Metabolics *
MillamoleculesMillamoleculesAntibody Antibody DrugDrugConjugatesConjugates
Exploratory Areas
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Metabolics
* Focus on progressing early* Focus on progressing early--development assets and transitioning latedevelopment assets and transitioning late--stage assets to AstraZenecastage assets to AstraZeneca
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BMY BMY Development Development Portfolio by Disease AreaPortfolio by Disease AreaData as of Feb 1, 2014Data as of Feb 1, 2014
Eldelumab(Anti-IP10)Eldelumab(Anti-IP10) NivolumabNivolumab
Phase IPhase I Phase III^Phase III^ Marketed ProductDevelopment †
Marketed ProductDevelopment †
Anti-CD28Anti-CD28 NULOJIX ®NULOJIX ®YERVOY ®YERVOY ®
Phase IIPhase II
Anti-LAG3Anti-LAG3
Factor XIa Inhibitor
Factor XIa Inhibitor NS5B Non NucNS5B Non NucHIV Attachment
InhibitorHIV Attachment
Inhibitor
UrelumabUrelumab
Denenicokin (IL-21)
Denenicokin (IL-21) Elotuzumab Elotuzumab ClazakizumabClazakizumabAnti-IL31Anti-IL31
Lirilumab(Anti-KIR)Lirilumab(Anti-KIR)
ELIQUIS ®ELIQUIS ®
BARACLUDE®BARACLUDE®ERBITUX®ERBITUX®
SPRYCEL®SPRYCEL®
IKur InhibitorIKur Inhibitor
PeginterferonPeginterferon
DaclatasvirDaclatasvir
AsunaprevirAsunaprevir
Urelumab(Anti-CD137)
Urelumab(Anti-CD137)
JAK2 InhibitorJAK2 Inhibitor
Anti PD L1Anti PD L1Notch InhibitorsNotch Inhibitors
NRT InhibitorNRT Inhibitor
HIV Program++HIV Program++
LPA1 A t i tLPA1 A t i t
ORENCIA®ORENCIA® REYATAZ®REYATAZ®
PAR4 AntagonistPAR4 Antagonist
Peginterferon lambda-1a
Peginterferon lambda-1a
Anti-CXCR4Anti-CXCR4
Anti-PD-L1Anti-PD-L1Notch Inhibitors Notch Inhibitors LPA1 AntagonistLPA1 Antagonist
CCR2 / 5 (1) AntagonistCCR2 / 5 (1) Antagonist
PEG-FGF21PEG-FGF21
CCR2 / 5 (2) AntagonistCCR2 / 5 (2) Antagonist
Anti-CD40LAnti-CD40L ^In Phase III development or currently^In Phase III development or currentlyG GG Gt C 0t C 0
ONC IMMIO
VIR
CV
EA METFD
under regulatory reviewunder regulatory review
† Approved in at least one† Approved in at least onemajor market (US, EU, JP, CN)major market (US, EU, JP, CN)
++++Mechanism of Action is not disclosedMechanism of Action is not disclosed
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VIR EA METFD
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Improving the standard of care for stroke Improving the standard of care for stroke prevention in atrial fibrillationprevention in atrial fibrillation
Unique and differentiated profile supported Unique and differentiated profile supported by trials across multiple indicationsby trials across multiple indicationsy py p
Potential nearPotential near--term label expansion in VTE term label expansion in VTE prevention and treatment with PDUFAprevention and treatment with PDUFAprevention and treatment with PDUFA prevention and treatment with PDUFA dates in 2014dates in 2014
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Hepatitis C
BMS Dual TherapyDCV ASV Potential first all oralirst all oralDCV + ASV
• Potential Japan approval in 2014• US submission targeted in first half 2014
Potential first all oralirst all oraltreatment in Japantreatment in Japan
DCV + other HCV agents P t ti l EU l i 2014
Potential first NS5A irst NS5A Inhibitor in EUInhibitor in EU
BMS Triple Therapy
Potential EU approval in 2014 Inhibitor in EUInhibitor in EU
BMS Triple TherapyDCV + ASV + NS5B Non-Nuc
• Global Phase III program ongoing• US submission targeted in 2015
One tablet,ne tablet, twice dailytwice daily
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DCV = daclatasvirASV = asunaprevir
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Immuno-Oncology
Transformational opportunity in the treatment of cancer withTransformational opportunity in the treatment of cancer with Transformational opportunity in the treatment of cancer with Transformational opportunity in the treatment of cancer with potential application across multiple tumor types potential application across multiple tumor types
Likely role for monotherapy biomarker directed monotherapyLikely role for monotherapy biomarker directed monotherapy Likely role for monotherapy, biomarker directed monotherapy, Likely role for monotherapy, biomarker directed monotherapy, and combination therapyand combination therapy
Important to demonstrate and characterize overall survivalImportant to demonstrate and characterize overall survival Important to demonstrate and characterize overall survivalImportant to demonstrate and characterize overall survival
Comprehensive and flexible development programsComprehensive and flexible development programs
Broad IBroad I--O portfolioO portfolio
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YervoyYervoy: F: First Agent to Demonstrate Long-Term Survival in Some Patients with Metastatic Melanoma
Analysis of Pooled OS Data Analysis of Pooled OS Data
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Hodi, European Cancer Congress, September 2013
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Registrational Approved Phase IIPhase I
ImmunoImmuno--Oncology Oncology –– Development PortfolioDevelopment PortfolioImmunoImmuno--Oncology Oncology –– Development PortfolioDevelopment PortfolioData as of Feb 1, 2014Data as of Feb 1, 2014
Registrational IndicationsPhase IIPhase I
Elotuzumab*Elotuzumab*
YERVOY ®Unresectable or
Metastatic Melanoma
YERVOY ®Unresectable or
Metastatic Melanoma
Urelumab (Anti-CD137)Cancer
Urelumab (Anti-CD137)Cancer
YERVOY ®YERVOY ®
Elotuzumab* 1st line MM Revlimid
Combo
Elotuzumab* 1st line MM Revlimid
Combo
Elotuzumab* 2nd line MM
Velcade Combo
Elotuzumab* 2nd line MM
Velcade Combo
YERVOY ®+ Nivolumab*
1st line Melanoma
YERVOY ®+ Nivolumab*
1st line Melanoma Nivolumab*HCC
Nivolumab*HCC Ni ol mab*Ni ol mab* Elotuzumab*
Relapsed/RefractoryMM Revlimid Combo
Elotuzumab* Relapsed/RefractoryMM Revlimid Combo
YERVOY ®YERVOY ®
YERVOY ®Adjuvant Melanoma
YERVOY ®Adjuvant Melanoma
Nivolumab*2nd/3rd line RCC
Nivolumab*2nd/3rd line RCC
YERVOY ®Metastatic Melanoma
Dose Optimization
YERVOY ®Metastatic Melanoma
Dose Optimization
Ni l b*Ni l b*YERVOY ®
G t iYERVOY ®
G t i
HCCHCC
Anti-LAG3 +Anti-LAG3 +
Nivolumab*Cancer (solid tumor)
Nivolumab*Cancer (solid tumor)
Nivolumab*NHL (FL)^
Nivolumab*NHL (FL)^
Nivolumab*NHL (DLBCL)^
Nivolumab*NHL (DLBCL)^Nivolumab*
Hematologic Mal.Nivolumab*
Hematologic Mal.
YERVOY ®YERVOY ®
YERVOY ®1st line Sq NSCLC
YERVOY ®1st line Sq NSCLC
Nivolumab*2nd line Sq NSCLC
Nivolumab*2nd line Sq NSCLC
YERVOY ®Small Cell Lung
YERVOY ®Small Cell Lung
GastricGastric
YERVOY ®Ovarian
YERVOY ®Ovarian
Nivolumab*Nivolumab*
Nivolumab*2nd line NSq NSCLC
Nivolumab*2nd line NSq NSCLC
YERVOY ®Adolescent melanoma
YERVOY ®Adolescent melanoma
Anti LAG3 + Nivolumab*
Cancer
Anti LAG3 + Nivolumab*
CancerLirilumab + Nivolumab*
Cancer (solid tumor)
Lirilumab + Nivolumab*
Cancer (solid tumor)Denenicokin +Denenicokin +
Prostate (post-hormonal therapy)
Prostate (post-hormonal therapy)
3rd line Sq NSCLC3rd line Sq NSCLC
Nivolumab*2nd/3rd line Melanoma
Nivolumab*2nd/3rd line Melanoma
Nivolumab*1st line Melanoma
Nivolumab*1st line Melanoma AbbreviationsAbbreviations
CML: Chronic Myelogenous LeukemiaCML: Chronic Myelogenous LeukemiaDLBCL: Diffuse Large BDLBCL: Diffuse Large B--cell Lymphomacell Lymphoma
Nivolumab* + YERVOY ®
Glioblastoma^
Nivolumab* + YERVOY ®
Glioblastoma^
Nivolumab* +Nivolumab* +
Denenicokin Nivolumab*
Cancer (solid tumor)
Denenicokin Nivolumab*
Cancer (solid tumor)Lirilumab + YERVOY ®
Cancer (solid tumor)
Lirilumab + YERVOY ®
Cancer (solid tumor)
2nd/3rd line Melanoma2nd/3rd line Melanoma gg y py pFL: Follicular LymphomaFL: Follicular LymphomaHCC: Hepatocellular CarcinomaHCC: Hepatocellular CarcinomaMal: Malignancy, MetMal: Malignancy, Met: : MetastaticMetastaticMM: Multiple MyelomaMM: Multiple MyelomaNHL: NonNHL: Non--Hodgkin LymphomaHodgkin LymphomaNSqNSq: : NonNon--SquamousSquamous, Sq: Squamous, Sq: Squamous* Development Partnership* Development Partnership
Nivolumab* ^1st line NSCLC
(PD-L1 +)
Nivolumab* ^1st line NSCLC
(PD-L1 +)
Nivolumab YERVOY ®
Cancer (solid tumor)
Nivolumab YERVOY ®
Cancer (solid tumor)Nivolumab* +
YERVOY ®Cancer (NSCLC)
Nivolumab* + YERVOY ®
Cancer (NSCLC)Nivolumab* + Nivolumab* +
NOT FOR PRODUCT PROMOTIONAL USE
qq qq , q q, q qNSCLC: NSCLC: Non Non Small Cell Lung CancerSmall Cell Lung CancerRCC: RCC: Renal Renal Cell Cell CarcinomaCarcinoma
Nivolumab: Ono Pharmaceuticals; Elotuzumab: AbbVie;Nivolumab: Ono Pharmaceuticals; Elotuzumab: AbbVie;Lirilumab: Innate PharmaLirilumab: Innate Pharma^Published on ClinicalTrials.gov, not yet recruiting^Published on ClinicalTrials.gov, not yet recruiting
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YERVOY ®Cancer (RCC)YERVOY ®
Cancer (RCC)Nivolumab* + SPRYCEL®
CML^
Nivolumab* + SPRYCEL®
CML^
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Key Data Flow & Events: 2014Key Data Flow & Events: 2014 Potential approval in VTE treatment in the US and EUPotential approval in VTE treatment in the US and EU Potential approval in VTE prevention in the USPotential approval in VTE prevention in the US
yy
Hepatitis C Hepatitis C PortfolioPortfolio
Potential approval of daclatasvir and asunaprevir in Japan (DUAL)Potential approval of daclatasvir and asunaprevir in Japan (DUAL) Potential approval of daclatasvir in the EUPotential approval of daclatasvir in the EU Potential submission of daclatasvir and asunaprevir in the USPotential submission of daclatasvir and asunaprevir in the US
Adjuvant melanoma dataAdjuvant melanoma data Additional combination data with nivolumabAdditional combination data with nivolumab
Potential submission of daclatasvir and asunaprevir in the USPotential submission of daclatasvir and asunaprevir in the US
Data from Phase II 3Data from Phase II 3rdrd line squamous NSCLCline squamous NSCLC Phase I combinations in NSCLC and renalPhase I combinations in NSCLC and renal Additional followAdditional follow--up, including long term survival, from Phase Iup, including long term survival, from Phase INivolumabNivolumab Additional followAdditional follow up, including long term survival, from Phase I up, including long term survival, from Phase I
monotherapy study in lung, renal and melanomamonotherapy study in lung, renal and melanoma Additional followAdditional follow--up, including long tem survival, from Phase I combination up, including long tem survival, from Phase I combination
study with ipilimumab in melanoma study with ipilimumab in melanoma Data from Phase IData from Phase I monotherapymonotherapy study in hematological malignanciesstudy in hematological malignancies
Nivolumab Nivolumab (Anti(Anti--PD1)PD1)
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Note: Dependent Note: Dependent on data availability, acceptance of medical meeting submissions or health authority actionson data availability, acceptance of medical meeting submissions or health authority actions
Data from Phase I Data from Phase I monotherapymonotherapy study in hematological malignanciesstudy in hematological malignancies Initiation of additional trials and in additional indications Initiation of additional trials and in additional indications
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CowenCowenCowenCowenHealth Care ConferenceHealth Care Conference
Brian Daniels, M.D.Brian Daniels, M.D.Brian Daniels, M.D.Brian Daniels, M.D.Senior Vice President, Senior Vice President,
Global Development & Medical AffairsGlobal Development & Medical AffairsGlobal Development & Medical AffairsGlobal Development & Medical Affairs
March 4, 2014March 4, 2014
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