Bristol-Myers Squibb -- Barclays Global Healthcare Conference
Barclays Global Healthcare Conference
Michael Giordano, M.D. Senior Vice President, Head of Development Oncology & Immunology
March 12, 2013
NOT FOR PRODUCT PROMOTIONAL USE 1 Forward-Looking Information
During this meeting, we will make statements about the Company’s future plans and prospects that constitute forward- looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated as a result of various important factors, including those discussed in the company’s most recent annual report on Form 10-K and reports on Form 10-Q and Form 8-K. These documents are available from the SEC, the Bristol-Myers Squibb website or from Bristol-Myers Squibb Investor Relations. In addition, any forward-looking statements represent our estimates only as of today and should not be relied upon as representing our estimates as of any subsequent date. While we may elect to update forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our estimates change.
NOT FOR PRODUCT PROMOTIONAL USE 2 R&D Delivery of Our BioPharma Strategy
Best of Biotech Best of Pharma Next Generation BioPharma
Selective Continuous Innovation Integration Improvement
Delivered 14 new Executed String of Achieved $600 medicines in 10 years Pearls Strategy million in annual cost savings and Robust pipeline of Successful avoidance new medicines and co-development & new indications & co-commercialization formulations strategic partnerships Strategy and capabilities in place to sustain R&D success
NOT FOR PRODUCT PROMOTIONAL USE 3 BMS Oncology Strategic Focus
Extend Immuno-Oncology leadership
Sustain and expand hematology franchise
Leverage targeted medicine principles in development and commercialization strategies
Accelerate Antibody Drug Conjugate (ADC) technology development
Maximize value through geographic diversity
Develop and align access strategies to build the value proposition and ensure commercial success of pipeline assets
NOT FOR PRODUCT PROMOTIONAL USE 4 Data as of Dec 31, 2012 Oncology – Development Portfolio Approved IND / Phase I Phase II Phase III / Registrational Indications
® Elotuzumab* Elotuzumab* Nivolumab* YERVOY Anti-Fucosyl GM1 (ipilimumab) Lung 2nd line MM 1st line (Anti-PD-1) nd Unresectable or Metastatic Velcade Combo MM Revlimid Combo 2 line Melanoma Melanoma JAK2 Inhibitor Elotuzumab* ® ® MPD Elotuzumab* YERVOY SPRYCEL 2nd line MM Relapsed/Refractory 1st line Metastatic (dasatinib) Thalidomide Combo MM Revlimid Combo Melanoma Refractory CML IL-21 Cancer ® Nivolumab* ® YERVOY YERVOY ® SPRYCEL Gastric (Anti-PD-1) (dasatinib) Lirilumab nd Adjuvant Melanoma st (Anti-KIR) 2 line RCC 1 line CML Cancer YERVOY ® Nivolumab* YERVOY ® ERBITUX® * Ovarian Urelumab (Anti-PD-1) 1st line Sq Non Small (cetuximab) (Anti-CD137) 2nd line Sq NSCLC Cell Lung Pretreated Metastatic Cancer SPRYCEL® Colorectal Pediatric Nivolumab* Notch Inhibitor (1) YERVOY ® ERBITUX® * (Anti-PD-1) (cetuximab) Cancer nd Small Cell Lung SPRYCEL® 2 line NSq NSCLC Loc. Adv. Head & Neck Pancreatic Notch Inhibitor (2) Nivolumab* YERVOY ® ERBITUX® * Cancer (Anti-PD-1) Prostate (cetuximab) 3rd line Sq NSCLC (post hormonal therapy) Met Head & Neck after Anti-CXCR4 platinum-based therapy Hematologic Mal. Nivolumab* YERVOY ® ERBITUX® * (Anti-PD-1) Prostate (cetuximab) Anti-LAG3 1st line Melanoma (post chemotherapy) 1st line Met Head & Neck Cancer ERBITUX® * ERBITUX® * Anti-PD-L1 Esophageal (cetuximab) Solid Tumor 1st line Colorectal Nivolumab* (Anti-PD-1) Abbreviations: Solid Tumor CML: Chronic Myelogenous Leukemia Nivolumab* (Anti-PD-1) Loc. Adv.: Locally Advanced Hematologic Mal. Mal: Malignancies, Met: Metastatic * Development Partnership MPD: Myeloproliferative Disorder Nivolumab (Anti-PD-1): Ono Pharmaceuticals; Elotuzumab: Abbott; NSq: Non-Squamous, Sq: Squamous Erbitux: Eli Lilly;Sprycel: Otsuka NSCLC: Non Small Cell Lung Cancer RCC: Renal Cell Carcinoma NOT FOR PRODUCT PROMOTIONAL USE 5 Multiple BMS Approaches to Immuno-Oncology
CD80 CD28 Ipilimumab CD86 (approved) CTLA-4 Antigen- Tumor Antigen Presenting Cell MHC TCR T-Cell Anti LAG3 LAG3 (Preclinical) LAG3 PD-L1 Nivolumab PD-1 (Phase III) PD-L2
Urelumab 4-1BBL (Phase II) 4-1BB
NOT FOR PRODUCT PROMOTIONAL USE 6 Immuno-Oncology Pipeline
Early Stage Late Stage
Lirilumab YERVOY (anti-KIR) (ipilimumab)
Urelumab Nivolumab (anti-CD137) (anti-PD1)
Denenicokin Elotuzumab (interleukin 21)
LAG3 Antibody
Leveraging our innovative Immuno-Oncology Network to further our understanding in this area
NOT FOR PRODUCT PROMOTIONAL USE 7 Leading The Way in Immuno-Oncology
First metastatic melanoma therapy approved in over a decade
Continued evidence of long-term survival in some patients
Ongoing development in metastatic melanoma & additional indications
– Exploring optimal dosing regimen
– Adjuvant melanoma
NOT FOR PRODUCT PROMOTIONAL USE 8 Nivolumab: Fully Human Anti-PD1 Antibody In Development For Multiple Tumor Types
2012 nivolumab data showed durable responses with acceptable and manageable safety profile
Cumulative Objective Response Rates Across All Doses NSCLC 18%
Renal Cell 27%
Melanoma 28%
NSCLC: Brahmer, J.R., et al. ASCO 2012 Renal Cell: McDermott, D.F., et al. ASCO 2012 Melanoma: Hodi, F.S., et al. ASCO 2012 NOT FOR PRODUCT PROMOTIONAL USE 9 Nivolumab Comprehensive Phase III Program
NSCLC • Squamous 2nd-line vs. docetaxel • Non-squamous 2nd-line vs. docetaxel
Advanced / metastatic Renal Cell vs. everolimus
Broad program covering Melanoma all lines of therapy
NOT FOR PRODUCT PROMOTIONAL USE 10 Elotuzumab: Anti-CS1 Antibody in Development for Multiple Myeloma (MM)
ASH 2012 Ph II data in relapsed MM patients showed: – High objective response rate – Long progression-free survival – Acceptable safety and tolerability
Ph III ongoing in first-line MM and relapsed or refractory MM in combination with revlimid
NOT FOR PRODUCT PROMOTIONAL USE 11 Elotuzumab Progression Free Survival at ASH 2012
100 90 80 70
60 10 mg/kg 50 40 Proportion of 30 20 mg/kg Median Time to Progression/Death: 20 10 mg/kg (n=36): not yet reached ProgressionFree Patients (%) 10 20 mg/kg (n=37): 18.6 mos (95% CI 12.9-29.7) 0 0 3 6 9 12 15 18 21 24 27 30 33 Months
At a median follow-up of 20.8 months, median PFS has not been reached in the 10 mg/kg arm
Richardson, P.G., et al. ASH 2012 NOT FOR PRODUCT PROMOTIONAL USE 12 Pursuing Innovative Partnerships to Further Immuno-Oncology (I-O)
International I-O Network Optimize effectiveness of Dana Farber Johns our I-O assets by studying Cancer Inst. Hopkins Univ. them in rational Navarra combinations and pre- National Cancer Univ. - Spain clinical models to better Inst. - Italy understand the complex Earl Chiles Research tumor-host immune Institute relationship Identify and deploy the use of biomarkers for I-O Netherlands therapeutics Univ. of Cancer Inst. Biomarkers Chicago Translate this science into clinical trials and eventual Royal clinical practice Marsden - UK Memorial Inst. Gustave Sloan-Kettering Roussy - France
NOT FOR PRODUCT PROMOTIONAL USE 13 What is Targeted Medicine?
Targeted Medicine is the information, tools and medicines to enable selection of the right drug for the right patient for a superior outcome
Treat Diagnostic* 86% benefit from therapy
Plate 0000066592 Proc e ss Group 0799006 Ma rke r WI7466-1 (#592)
3.5 Sta tus: GetGenos Pass User: vish Pass
3 Unknowns: #Wells Passed 84 Failed 0 2.5 Averages X Y XX 2.77 0.14 Don’t Treat? XY 2.78 2.65 2 YY 0.15 2.74 A/A Neg. Unknown Synthetic Temp Controls: (Max) 1.5 X Y NEG - PCR 0.12 0.07 60% benefit from Syn 2.68 0.36 1 A/C
0.5
0 therapy 0 0.5 1 1.5 2 2.5 3 3.5 C/C Try alternate therapy
High response to therapy Low response to therapy
* Specific blood, tissue or imaging marker that can be used to prospectively identify patients for efficacy, safety and/or dose
NOT FOR PRODUCT PROMOTIONAL USE 14 BMS Approach to Pharmacodiagnostic Capabilities
BMS “Virtual Asset PDx Program Pharmacodiagnostics” K-ras mutation PCR test Objective is to obtain optimal, streamlined access to best-fit PDx PDL-1 expression IHC test ‘companies’ to support each asset as CSF protein biomarker needed immunoassays • Strategic fit with BMS BioPharma Drug sensitivity phenotype assay model and selective integration • Partnering strategies to mitigate Anti-Factor Xa activity assay risk; goal is timely approvals and patient access to BMS Rx in all Fucosyl-GM1 Assay markets Gene Rearrangement/Mutation • Flexible access to PDx expertise Assay and capabilities quickly, efficiently, at reasonable cost Quantitative HBsAg Assay
NOT FOR PRODUCT PROMOTIONAL USE 15 2013 Oncology Key Data Flow & Events
Ipilimumab + vemurafenib safety/feasibility data Yervoy Prostate data (2nd line docetaxel pretreated CRPC) Additional melanoma data (five year survival from Ph II rollover, EAP data), additional data on biomarkers: ASCO, June
Additional Phase I/II data from multiple tumor types (e.g., RCC, melanoma, Nivolumab lung) including survival data and biomarker data: ASCO, June (Anti-PD1) Ipilimumab + nivolumab dosing data: ASCO, June
Sprycel Phase III prostate (castration resistant): ASCO GU, February First line CML 4 year data, second line CML 7 year data: ASH, December
Elotuzumab Update of Phase II results: various medical meetings
Note: Dependent on data availability, acceptance of medical meeting submissions or health authority actions NOT FOR PRODUCT PROMOTIONAL USE 16 Barclays Global Healthcare Conference
Michael Giordano, M.D. Senior Vice President, Head of Development Oncology & Immunology
March 12, 2013
NOT FOR PRODUCT PROMOTIONAL USE 17