Cowen Health Care Conference

Transcription

1 Cowen Health Care Conference Francis Cuss, MB BChir, FRCP Senior Vice President, Research March 6,

2 Forward-Looking Information During this meeting, we will make statements about the Company s future plans and prospects that constitute forwardlooking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 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. 2

3 BMS BioPharma Strategy Best of Biotech Best of Pharma Helping more patients prevail in their fight against serious disease Next-Generation BioPharma Innovation Selective Integration Continuous Improvement Agile, Entrepreneurial & Accountable Culture 3

4 Pipeline Delivery Has Positioned BMS Well for the Future Schizophrenia, Depression Rheumatoid Arthritis Cardiovascular Disease Diabetes HIV / AIDS Cancer Cancer Transplant Cancer Cancer HIV / AIDS Diabetes Hepatitis B Diabetes First Market Approval (US or EU) * First Market Approval (US or EU) 4

5 NME Development Portfolio Data as of Feb 15, 2013 Exploratory Development * Full Development ^ Marketed Product Development Anti-Fucosyl GM1 JAK2 Inhibitor Denenicokin (IL-21) Lirilumab (Anti-KIR) Urelumab (Anti-CD137) Notch Inhibitors Anti-CXCR4 Anti-LAG3 GPR119 Agonist PEG-FGF21 11βHSD Inhibitor ONC GPR40 Agonist Anti-CD40L Anti- CD40 Anti-CD28 Anti-IL31 Anti-IP10 IL-17/IL-23 biab S1P1 Modulator LPA1 Antagonist CCR1 Antagonists Clazakizumab (Anti-IL6) LXR Modulators PCSK9 Adnectin CCR2 / 5 Antagonists IKur Antagonists Factor XIa Inhibitor (Parenteral) Factor XIa Inhibitor (Oral) PEG-Relaxin HIV Attachment Inhibitor NRT Inhibitor HIV Maturation Inhibitor Anti-PD-L1 MET IMM CV VIR NS NS5B Non Nuc α-7 Nicotinic Agonist Gamma Secretase Modulator Triple Reuptake Inhibitors Microtubule Stabilizer Myostatin Adnectin Nivolumab (Anti-PD1) Elotuzumab Metreleptin Daclatasvir (NS5A Inhibitor) Asunaprevir (NS3 Inhibitor) Peginterferon lambda-1a **FORXIGA is not approved in the US YERVOY (ipilimumab) SPRYCEL (dasatinib) ERBITUX (cetuximab) FORXIGA TM ** (dapagliflozin) ONGLYZA (saxagliptin) KOMBIGLYZE TM XR (saxagliptin + metformin) SYMLIN (pramlintide acetate) BYETTA (exenatide) BYDUREON (exenatide extended-release) ORENCIA (abatacept) NULOJIX (belatacept) ELIQUIS (apixaban) BARACLUDE (entecavir) REYATAZ (atazanavir sulfate) SUSTIVA (efavirenz) ATRIPLA (efavirenz/emtricitabine/ tenofovir disoproxil fumarate) * Post discovery through Phase II ^ Registrational program Approved in at least one major market 5

6 Pipeline Key Areas of Focus Immuno-Oncology Hepatitis C 6

7 Immuno-Oncology Pipeline Early Stage Lirilumab (anti-kir) Urelumab (anti-cd137) Denenicokin (interleukin 21) Late Stage YERVOY (ipilimumab) Nivolumab (anti-pd1) Elotuzumab LAG3 Antibody Leveraging our innovative Immuno-Oncology Network to further our understanding in this area 7

8 Multiple BMS Approaches to Immuno-Oncology CD80 CD86 Antigen- Presenting Cell MHC Anti LAG3 (Preclinical) Tumor Antigen Ipilimumab (approved) TCR LAG3 CD28 CTLA-4 T-Cell PD-L1 PD-L2 Nivolumab (Phase III) PD-1 4-1BBL Urelumab (Phase II) 4-1BB 8

9 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 9

10 Nivolumab Data In 2012 Cumulative Objective Response Rates Across All Doses NSCLC 18% Renal Cell 27% Melanoma 28% Data showed durable responses with acceptable and manageable safety profile 10

11 Nivolumab Comprehensive Phase III Program NSCLC Squamous Non-squamous Renal Cell Melanoma 2 nd -line vs. docetaxel 2 nd -line vs. docetaxel Advanced / metastatic vs. everolimus Broad program covering all lines of therapy 11

12 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 12

13 Pipeline Key Areas of Focus Immuno-Oncology Hepatitis C 13

14 BMS Strategy: A Multipronged Approach to Optimize Hepatitis C Opportunity Current Standard of Care Potential Future Treatment Options Pegylated Interferon-α + Ribavirin + Telaprevir or Boceprevir Direct Acting Antiviral(s) +/- Ribavirin Novel Lambda Interferon +/- Direct Acting Antiviral(s) +/-Ribavirin Pegylated Interferon-α + Ribavirin + Direct Acting Antiviral(s) 14

15 Dual Therapy (Daclatasvir + Asunaprevir) Opportunity in Japan ~1.5M people infected; ~70% are GT1b Potential first all oral regimen to market Ph IIa data showed 90% SVR 24 in HCV GT1b Ph III data to be presented at AASLD Potential submission late-2013 Chayama K, et al. AASLD

16 Triple Therapy (Daclatasvir + Asunaprevir + NS5B Non-Nuc) in Treatment Naïve GT1 Patients 24-Week Treatment (N = 16) 12-Week Treatment (N = 16) Patients achieving endpoint (%) a EOT SVR 4 b 100 Study Week Ph IIb study ongoing in ~300 patients Ph III start expected by early b 4 12 EOT SVR SVR 4 12 HCV RNA < LLOQ Missing data HCV RNA < LLOQ Missing data a Includes 1 patient with HCV RNA 118 IU/mL at last on-treatment visit but < LLOQ TND 2 and 4 weeks posttreatment (SVR 4 ). b EOT, end of treatment; includes patients who discontinued prior to the protocol-defined last treatment visit. < LLOQ TD or TND, HCV RNA below assay lower limit of quantitation (25 IU/mL) Everson GT, et al. AASLD Oral LB-3 16

17 Pipeline Key Areas of Focus Immuno-Oncology Hepatitis C 17

18 Sustaining Our Success R&D Continuity of Strategy and Leadership Company Focus on BioPharma Research Quality Approach Development Follow the Science Philosophy Regulatory Interactive & Transparent R&D Creative Partnerships 18

19 2013 Key Data Flow & Events Eliquis Onglyza Bydureon Dapagliflozin Yervoy Nivolumab (Anti-PD1) VTE treatment (AMPLIFY) results 2Q2013 CV outcomes (SAVOR) top-line results mid-2013 Dual-chamber pen submission US resubmission targeted mid-2013; Japan submission in 1H2013 Ipilimumab + vemurafenib safety / feasibility data Prostate data (2 nd line docetaxel pretreated CRPC) Additional melanoma data (five year survival from Ph II rollover), additional data on biomarkers: ASCO, June Additional Phase I/II data from multiple tumor types including survival data and biomarker data: ASCO, June Ipilimumab + nivolumab dosing data: ASCO, June Hepatitis C Portfolio Additional Ph II data from triple therapy in GT1 naïve patients: EASL Ph III dual in Japanese GT1b patients: SVR24 and resistance data: AASLD Note: Dependent on data availability, acceptance of medical meeting submissions or health authority actions 19

20 Cowen Health Care Conference Francis Cuss, MB BChir, FRCP Senior Vice President, Research March 6,