Cowen Health Care Conference

Transcription

1 Cowen Health Care Conference Brian Daniels, M.D. Senior Vice President, Global Development and Medical Affairs March 17, 2009

2 2 During this meeting, we will make statements about the Company s s future plans and prospects, including statements about our financial position, business strategy, research pipeline concerning product development and product potential, that constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the company s s most recent annual report on Form 10-K, periodic reports on Form 10-Q Q and current reports on Form 8-K. 8 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 en if our estimates change.

3 3 BMS Vision for the Future Next Generation BioPharma Leader Best of Biotech Best of Pharma Next Generation BioPharma Innovate Integrate Improve Agile, Entrepreneurial and Accountable Culture

4 Selective Integration: String of Pearls Zymo- Genetics Kosan Hepatitis C HCV NS5A inhibitor, HCV target #2, HCV target #3 Exelixis Isis KAI Alzheimer's Gamma Secretase Cardiology Apixaban Teijin / Nissan Kosan Solid Tumor Brivanib, anti-cd137, EVRI, AR, Epo Folate, IGF, Met Kinase,, Cdc7 Adnexus Medarex Exelixis Hematologic Malignancy Sprycel PDL Exelixis Kosan

5 5 Recent Additions to Our String of Pearls ZymoGenetics (January 14, 2009) Novel type 3 interferon in Phase Ib for the treatment of hepatitis C First biologic in our virology pipeline Nissan Chemical / Teijin Pharma (March 5, 2009) Novel, targeted oral inhibitor of the acetylcholine- activated potassium channel (IKACh( IKACh) In Ph I development in Japan for the maintenance of normal sinus rhythm in patients with atrial fibrillation

6 Continuous Improvement: Building on a Strong Track Record of Success Pfizer Merck GSK BMS J&J Novartis Amgen Roche Wyeth Eli Lilly S-A Abbott AZ Priority Non-Priority Average FDA Review Time (Months) n/a 2008E Pharm R&D Spend ($B) $7.5 $4.6 $6.6 $ $5.1 $5.7 $3.0 $7.3 $3.1 $3.7 $6.7 $2.2 n/a $ US NME Approvals with FDA Review Status and Median Review Time Note: Includes compounds designated as classification 1 (NDA chemical type new molecular entity) by the FDA. Novel biologics and vaccines are included. Roche total includes compounds Genentech filed in the US (i.e., Avastin, Tarceva) for which Roche had significant development participation. Spend for companies not reporting in $US converted using average exchange rate for Source: PhRMA, FDA, Company reports, BMS analysis 6

7 Marketed Product Development IXEMPRA (Cancer) SPRYCEL (Cancer) Erbitux (Cancer) ORENCIA (Rheumatoid Arthritis) PLAVIX (Atherothrombosis Atherothrombosis) AVAPRO / AVALIDE (Hypertension) ABILIFY (Psychiatric Disorders) BARACLUDE (Hepatitis B) REYATAZ (HIV/AIDS) SUSTIVA / ATRIPLA (HIV/AIDS) Development Portfolio Full Development (Registrational, Filed) 7 Ipilimumab (Cancer) Brivanib (Cancer) Tanespimycin (Cancer) XL-184 XL (Cancer) Belatacept (Solid Organ Transplant) ONGLYZA (saxagliptin) (Diabetes) Dapagliflozin (Diabetes) Apixaban (Thrombosis) Exploratory Development (Preclinical, Phase I, Phase II) As of January 15, 2009 Androgen Receptor Antagonist (Cancer) IGF-1R Antagonist (Cancer) VEGF R-2 R Inhibitor - Adnectin (Cancer) ErbB/VEGF Receptor Inhibitor (Cancer) Anti-CD137 Antibody (Cancer) Epothilone-Folate (Cancer) SMO Inhibitor (Cancer) Cdc7 Inhibitor (Cancer) Anti-CS1 Antibody (Cancer) VEGFR/IGFR - Adnectin (Cancer) RAF Kinase Inhibitor (Cancer) p38 Kinase Inhibitors (Rheumatoid Arthritis) CCR1 (Rheumatoid Arthritis) GR Agonists (Immunology) 11βHSD Inhibitors (Diabetes) MCHR1 (Obesity) CCR2 Antagonist (CV / Met) DGAT Inhibitor (CV / Met) LXR Agonists (Atherosclerosis) PCSK9 Inhibitor (Cardiovascular) Delta PKC Inhibitor (Cardiovascular) Triple Reuptake Inhibitors (Depression) Gamma Secretase Inhibitor (Alzheimer s) HCV NS5A Inhibitors (Hepatitis C) HCV Target 2 Inhibitor (Hepatitis C) HCV Target 3 Inhibitor (Hepatitis C) PEG-Interferon Lambda (Hepatitis C) HIV Attachment Inhibitor (HIV/AIDS)

8 8 Potential Late-Stage CV/Met 2009 Milestones Ph III Acute Coronary Syndrome start Advisory committee meeting US action date Onglyza (Saxagliptin) Dapagliflozin Apixaban EU approval decision US submission for once- daily, fixed- dose combo w/ metformin 1Q Q 2009 ADA: Mechanism of action study Ph III long-term extension ADA: Ph IIb study in severely insulin-resistant patients 3Q2009 4Q 2009 ISTH: EASD: Initial Ph III data Ph II DVT prevention (cancer) ASH: Ph III DVT prevention (hip) Ph III EU DVT prevention (knee)

9 9 Belatacept: Our Next Submission Novel co-stimulation blocker developed to replace cornerstone therapy in solid organ transplantation Significant medical need to improve long-term outcomes in renal transplant Ph III trials against Cyclosporine focused on improving long-term outcomes Renal function: key predictor of long-term graft survival Ph III data at American Transplant Congress, May 09 Planned 2009 submissions: US 1H, EU 2H Ongoing development for steroid avoidance, conversion, liver transplant and subcutaneous

10 As of January 15, Oncology Development Portfolio Exploratory Development Full Development Marketed Product Development Immunotherapy Anti-CD137 Ipilimumab Hormonal Therapy Androgen receptor antagonists Angiogenesis VEGFR-2 2 inhibitor (Adnectin) ErbB/VEGF inhibitor VEGFR/IGFR (Adnectin) Brivanib Targeted Therapies IGF-1R antagonist Anti-cs1 SMO inhibitor RAF Kinase Inhibitor Tanespimycin XL-184 Erbitux Sprycel Cytotoxics Epothilone-folate Cdc7 Ixempra

11 11 Ipilimumab: New Immunotherapy Paradigm for Cancer Initial indication: metastatic melanoma Registrational program: Combination with DTIC for 1 st -line Monotherapy for 2 nd -line Continuing to update monotherapy survival data 12-month survival: ~50% 18-month survival: ASCO, June month survival: ESMO, Sept 09 Development in prostate and lung cancers

12 12 Brivanib: Novel Dual Kinase Inhibitor with Broad Anti-cancer Potential Oral anti-cancer small molecule First dual selective inhibitor of FGF and VEGF pathways Ph II FGF focused study Ph II hepatocellular carcinoma: encouraging activity, generally well-tolerated Registrational Program Hepatocellular carcinoma (HCC) Colorectal cancer Post-sorafenibsorafenib brivanib vs. placebo Head-to-head, brivanib vs. sorafenib in 1 st -line Adjuvant to TACE, brivanib vs. placebo Combination of brivanib with Erbitux vs. placebo

13 13 Brivanib: Ph II Study, Single-Agent in HCC Proportion Alive Overall Survival Median (95% CI) 10.0 mo (6.8, -) Note: : 24 Events, 31 Censored Months Subjects at Risk Brivanib

14 14 Tanespimycin: Potential in Multiple Tumor Types Potential first in class Heat Shock Protein 90 (HSP90) Inhibitor from Kosan acquisition Induces protein degradation, resulting in degradation of cancer signaling molecules and tumor cell death Pathway is broadly applicable in solid and liquid tumors Initial indication: Multiple myeloma Ph II activity in combination with bortezomib Ph III ongoing Promising Ph II breast cancer data

15 15 XL-184: Targeting a Variety of Solid Tumor Types Through Partnership with Exelixis Small molecule inhibitor of MET/RET/VEGFR2 which plays an important role in tumor growth and progression Joint development team with Exelixis Development in glioblastoma Multiple mechanisms: MET, VEGFR2 Encouraging clinical data to date Three ASCO abstracts, June 09 Ph III development for medullary thyroid cancer

16 16 Hepatitis C Virus (HCV): Unmet Medical Need 200 million infections worldwide, 5 million in the US Major cause of cirrhosis and hepatocellular carcinoma leading to ~10,000 deaths per year Current standard of care 40-50% sustained response rate 20-50% incidence of side effects often leading to reduction in dosage or discontinuation Death rate predicted to increase dramatically over the next 20 years in the absence of effective therapy

17 17 Multi-pronged Strategy for HCV Treatment Multiple approaches Small molecule antivirals as add-on to interferon Small molecule antiviral combinations to replace interferon Next generation interferon with fewer side effects to replace current interferon Current HCV Pipeline Interferon lambda from ZymoGenetics showing antiviral activity without typical interferon side effects Three mechanistically distinct, internal compounds in the clinic

18 HCV NS5A: Mean Change in HCV RNA from Baseline Following a Single Dose 0 log 10 HCV RNA (IU/mL) Time (hours) 144 Placebo n=2 BMS mg n=6 BMS mg n=5 BMS mg n=5 Proof-of-concept study, AASLD, November

19 19 Alzheimer s s Disease Unmet Medical Need Affects over 24 million people worldwide Prevalence expected to quadruple by 2050 due to aging population and lack of disease-modifying agents Current therapies offer transient symptomatic benefit Current Approach: Target the two hallmarks of Alzheimer s s Disease Amyloid plaques: gamma secretase inhibitors Tangles: microtubule stabilizers (internal and Kosan)

20 Gamma Secretase: Dose-dependent Reductions in Human CSF Aβ40/42A CSF Aβ (% baseline) Dose, mg A β 40 A β 42 BMS Study CN , ICAD, July

21 Note: Dependent on data availability, acceptance of medical meeting submissions or health authority actions As of March Projected Key Data Flow & Events Onglyza (Saxagliptin) Dapagliflozin Mechanism of action study: ADA, June Phase III long-term safety & efficacy: ADA, June US & EU approval decisions US submission for once-daily, fixed-dose dose combination with metformin Ph IIb highly insulin refractory study -009: ADA, June Initial Ph III data: EASD, Sept Erbitux Ongoing discussions with FDA for head & neck cancer and lung can Ipilimumab Ongoing discussions with FDA for head & neck cancer and lung cancercer 18-month survival data, ASCO, June 24-month survival data, EMSO, Sept Brivanib Initiation of Ph III hepatocellular carcinoma Abilify US submission for irritability associated with autistic disorder Plavix CURRENT data Apixaban Orencia Belatacept Initiation of Ph III acute coronary syndrome Ph III EU DVT prevention data: ISTH, July Ph III DVT prevention in cancer data: ASCO, June and ISTH, July Ph III DVT prevention data: ASH, December Ph III subcutaneous safety data: ACR, October Ph II psoriatic arthritis data: ACR, October Ph III data: American Transplant Congress, May US & EU submissions

22 Cowen Health Care Conference Brian Daniels, M.D. Senior Vice President, Global Development and Medical Affairs March 17, 2009