Cowen Health Care Conference · Broad IBroad I--O portfolioO portfolio NOT FOR PRODUCT PROMOTIONAL...

12
Cowen Cowen Cowen Cowen Health Care Conference Health 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 Affairs Global Development & Medical Affairs Global Development & Medical Affairs Global Development & Medical Affairs March 4, 2014 March 4, 2014 NOT FOR PRODUCT PROMOTIONAL USE 1

Transcript of Cowen Health Care Conference · Broad IBroad I--O portfolioO portfolio NOT FOR PRODUCT PROMOTIONAL...

Page 1: Cowen Health Care Conference · Broad IBroad I--O portfolioO portfolio NOT FOR PRODUCT PROMOTIONAL USE 8. YervoyYervoy: F: First Agent to Demonstrate Long-Term Survival in Some Patients

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

NOT FOR PRODUCT PROMOTIONAL USE 1

Page 2: Cowen Health Care Conference · Broad IBroad I--O portfolioO portfolio NOT FOR PRODUCT PROMOTIONAL USE 8. YervoyYervoy: F: First Agent to Demonstrate Long-Term Survival in Some Patients

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

NOT FOR PRODUCT PROMOTIONAL USE

so, even if our estimates change.so, even if our estimates change.

2

Page 3: Cowen Health Care Conference · Broad IBroad I--O portfolioO portfolio NOT FOR PRODUCT PROMOTIONAL USE 8. YervoyYervoy: F: First Agent to Demonstrate Long-Term Survival in Some Patients

Evolution of BioPharma StrategyEvolution of BioPharma StrategyEvolution of BioPharma StrategyEvolution of BioPharma Strategy

Specialty CareSpecialty CareBioPharmaBioPharma

InnovativeInnovativePharmaceuticalsPharmaceuticals

2007 2013

NOT FOR PRODUCT PROMOTIONAL USE 3

Page 4: Cowen Health Care Conference · Broad IBroad I--O portfolioO portfolio NOT FOR PRODUCT PROMOTIONAL USE 8. YervoyYervoy: F: First Agent to Demonstrate Long-Term Survival in Some Patients

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

NOT FOR PRODUCT PROMOTIONAL USE 4

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

Page 5: Cowen Health Care Conference · Broad IBroad I--O portfolioO portfolio NOT FOR PRODUCT PROMOTIONAL USE 8. YervoyYervoy: F: First Agent to Demonstrate Long-Term Survival in Some Patients

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

NOT FOR PRODUCT PROMOTIONAL USE 5

VIR EA METFD

Page 6: Cowen Health Care Conference · Broad IBroad I--O portfolioO portfolio NOT FOR PRODUCT PROMOTIONAL USE 8. YervoyYervoy: F: First Agent to Demonstrate Long-Term Survival in Some Patients

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

NOT FOR PRODUCT PROMOTIONAL USE 6

Page 7: Cowen Health Care Conference · Broad IBroad I--O portfolioO portfolio NOT FOR PRODUCT PROMOTIONAL USE 8. YervoyYervoy: F: First Agent to Demonstrate Long-Term Survival in Some Patients

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

NOT FOR PRODUCT PROMOTIONAL USE 7

DCV = daclatasvirASV = asunaprevir

Page 8: Cowen Health Care Conference · Broad IBroad I--O portfolioO portfolio NOT FOR PRODUCT PROMOTIONAL USE 8. YervoyYervoy: F: First Agent to Demonstrate Long-Term Survival in Some Patients

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

NOT FOR PRODUCT PROMOTIONAL USE 8

Page 9: Cowen Health Care Conference · Broad IBroad I--O portfolioO portfolio NOT FOR PRODUCT PROMOTIONAL USE 8. YervoyYervoy: F: First Agent to Demonstrate Long-Term Survival in Some Patients

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

NOT FOR PRODUCT PROMOTIONAL USE 9

Hodi, European Cancer Congress, September 2013

Page 10: Cowen Health Care Conference · Broad IBroad I--O portfolioO portfolio NOT FOR PRODUCT PROMOTIONAL USE 8. YervoyYervoy: F: First Agent to Demonstrate Long-Term Survival in Some Patients

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

10

YERVOY ®Cancer (RCC)YERVOY ®

Cancer (RCC)Nivolumab* + SPRYCEL®

CML^

Nivolumab* + SPRYCEL®

CML^

Page 11: Cowen Health Care Conference · Broad IBroad I--O portfolioO portfolio NOT FOR PRODUCT PROMOTIONAL USE 8. YervoyYervoy: F: First Agent to Demonstrate Long-Term Survival in Some Patients

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)

NOT FOR PRODUCT PROMOTIONAL USE 11

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

Page 12: Cowen Health Care Conference · Broad IBroad I--O portfolioO portfolio NOT FOR PRODUCT PROMOTIONAL USE 8. YervoyYervoy: F: First Agent to Demonstrate Long-Term Survival in Some Patients

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

NOT FOR PRODUCT PROMOTIONAL USE 12