bristol myerd squibb 26th Annual JPMorgan Healthcare Conference

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bristol myerd squibb 26th Annual JPMorgan Healthcare Conference

  1. 1. Research & Development Update JP Morgan Healthcare Conference January 7, 2008 Elliott Sigal, MD, PhD Executive Vice President Chief Scientific Officer & President, R&D Not for promotional use 1
  2. 2. During this meeting, we will make statements about the Company’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 1995. 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 most recent annual report on Form 10-K, periodic reports on Form 10-Q and current reports on 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 promotional use 2
  3. 3. Agenda Evolving to the Next Generation BioPharma Model R&D Strategy Pipeline Update Not for promotional use 3
  4. 4. Forces Driving Industry Change Increased regulatory / clinical requirements Decreased access to physicians by sales model Increased power of payers on pricing and prescribing Consolidation / cost-reduction across industry Not for promotional use 4
  5. 5. Evolution of Biotech and Pharmaceutical Companies ’80s/’90s 2000 – now Future Model Small More Biotechs Traditional consolidation? Biotech Major Biotechs Next Generation Model Mid-Cap Pharma More Traditional consolidation? Large Pharma Mega Focus on Pharma productivity/ execution Not for promotional use 5
  6. 6. Next Generation BioPharma Model Best of Pharma Best of Biotech Next Generation BioPharma Selectively Innovative Continuous Integrated Portfolio Improvement Business Model Nimble and Entrepreneurial Culture Not for promotional use 6
  7. 7. Innovative Portfolio Next Generation BioPharma Selectively Innovative Continuous Integrated Portfolio Improvement Business Model Innovative Portfolio: Implications to R&D Focus is on serious unmet medical needs in specialty and high prevalence disease areas Flexibility to choose the right modality for the right target Generation of clinical and economic data that demonstrate value for payers and patients Not for promotional use 7
  8. 8. Record of Priority Review is External Validation of Innovative Portfolio 2006 Average FDA Pharma Review Time R&D Spend (Months) ($B) Pfizer 6 $7.2 5 19 Merck 4 4 $4.5 8 BMS 6 1 $2.8 7 GSK 4 3 $6.2 14 Nov artis 2 5 $4.3 18 S-A 2 4 $5.6 23 Lilly 1 4 $3.0 18 Roche* 3 2 $4.7 11 Priority Non-Priority AZ 1 2 $3.8 16 W yeth 2 1 $2.9 15 1 J&J $5.0 2 10 0 1 2 3 4 5 6 7 8 9 10 11 US NME Approvals January 2002 – October 2007 with FDA Review Status and Average Review Time Note: Includes compounds designated as classification “1” (NDA chemical type – new molecular entity) by the FDA. Novel biologics and novel vaccines are included. * Includes compounds Genentech filed in the US (i.e., Avastin, Tarceva) for which Roche had significant development participation. Approval for Boniva credited to both Roche and GSK based on co-development agreement. Source: PhRMA, FDA, Company Reports, BMS internal analysis Not for promotional use 8
  9. 9. Selectively Integrated Business Model Next Generation BioPharma Selectively Innovative Continuous Integrated Portfolio Improvement Business Model Selectively Integrated Business Model: Implications to R&D External sources of innovation to complement internal capabilities Co-development and co-commercialization partnerships Focusing internal activities in core, high-value areas Not for promotional use 9
  10. 10. Co-development and Co-commercialization to Optimize the Value of a Pipeline Share risk and cost associated with large late- stage development investments Allow greater investment in broader portfolio Make big products even bigger by leveraging partner’s capabilities Apixaban Saxagliptin Dapagliflozin Not for promotional use 10
  11. 11. Focus on Continuous Improvement Next Generation BioPharma Selectively Innovative Continuous Integrated Portfolio Improvement Business Model Focus on Continuous Improvement: Implications to R&D Improving yield Increasing cost-effectiveness Not for promotional use 11
  12. 12. Nine New Drug Approvals in Less Than Five Years Cancer HIV / AIDS Depression Cancer Cancer Schizophrenia, Depression Rheumatoid Arthritis HIV / AIDS Hepatitis B 2007 2003 2004 2005 2006 Otsuka America Somerset ImClone Systems PHARMACEUTICALS INC. Incorporated Pharmaceutical, Inc. Not for promotional use 12
  13. 13. Bristol-Myers Squibb R&D Productivity Counter to Industry Trend 3 Yr Pharma R&D Spend 3 Yr R&D NME Approvals Industry Avg Industry Avg 12 $10 BMS BMS 11 $9 10 $8 9 $7 NME Approvals 8 $ Billions $6 7 $5 6 5 $4 4 $3 3 $2 2 $1 1 0 $0 R&D Spend: 1996-1998 1997-1999 1998-2000 1999-2001 2000-2002 2001-2003 NME Approvals: 2004-2006 1999-2001 2000-2002 2001-2003 2002-2004 2003-2005 Rolling 3 year totals for Pharma R&D spend vs. U.S. NME approvals Industry based on top 11 pharma companies Source: Company reports, PhRMA, BMS internal analysis Not for promotional use 13
  14. 14. Continuous Productivity Occurring Company-wide Management Council Productivity Transformation Team Supply Chain R&D G&A Commercial Operations $400 MM $200 MM $550 MM $350 MM $1.5 Billion Cost Savings + Cost Avoidance Not for promotional use 14
  15. 15. Agenda Evolving to the Next Generation BioPharma Model R&D Strategy Pipeline Update Not for promotional use 15
  16. 16. Building Pipelines Within Products: Full Development Programs Ipilimumab Belatacept Novel co-stimulation blocker Establishing a new developed to replace immunotherapy paradigm cornerstone therapy in solid for the treatment of cancer A new cytotoxic designed to organ transplantation overcome resistance Saxagliptin Dapagliflozin Apixaban Bringing a new choice Providing a new insulin- Predictable and reliable to the management of diabetes independent mechanism for anticoagulant with a wider – driven by the partnership of improved outcomes in therapeutic window than Bristol-Myers Squibb overweight and obese current standard of care and AstraZeneca diabetes patients Not for promotional use 16
  17. 17. Building Pipelines Within Products: Full Development Programs Ipilimumab Belatacept Novel co-stimulation blocker Establishing a new developed to replace immunotherapy paradigm cornerstone therapy in solid for the treatment of cancer A new cytotoxic designed to organ transplantation overcome resistance Saxagliptin Dapagliflozin Apixaban Bringing a new choice Providing a new insulin- Predictable and reliable to the management of diabetes independent mechanism for anticoagulant with a wider – driven by the partnership of improved outcomes in therapeutic window than Bristol-Myers Squibb overweight and obese current standard of care and AstraZeneca diabetes patients Not for promotional use 17
  18. 18. Current Therapies for Solid Organ Transplant Significant gains in one-year graft survival rates with current therapy Less progress on five-year patient and graft survival – 34% graft loss for deceased donors – 21% graft loss for living related donors Calcineurin inhibitors (CNIs) are associated with long-term complications – Increased risk of chronic allograft nephropathy leading to graft loss – Increased risk factors for cardiovascular disease – Increased risk of diabetes Not for promotional use 18
  19. 19. Belatacept Showed Comparable Efficacy and Improved Safety Over Cyclosporine at 1 Year Immunosuppressive Efficacy Low rates of acute rejection, comparable across arms Comparable patient and graft survival Safety Profile Low rates of serious infections and malignancies, comparable across arms Addressing Key Areas of Unmet Need Protection of renal function Lower rates of chronic allograft nephropathy Favorable trends in CV and metabolic parameters Phase II Study IM103-100, 12 month results, NEJM, 353:770, August 25, 2005 IM103- IM103-100, Not for promotional use 19
  20. 20. Belatacept Showed Stable Kidney Function Over Four Years Belatacept (N = 102) Calculated GFR (Glomerular Filtration Rate) Cyclosporine (N = 26) 90 (ml/min/1.73m2) 80 70 60 12 18 24 30 36 42 48 Months After Transplant Oral Presentations: 2007 ATC, San Francisco; 2007 ESOT, Prague Not for promotional use 20
  21. 21. Belatacept: Initial Registrational Program in Renal Transplant Study Study Design Endpoints N Broad-criteria belatacept vs. • Death/Graft Loss 660 donor cyclosporine • Renal function (GFR) • Acute rejection Extended- belatacept vs. 540 • Chronic allograft criteria donor cyclosporine nephropathy Planning for BLA submission in 1H 09 Not for promotional use 21
  22. 22. Building Pipelines Within Products: Full Development Programs Ipilimumab Belatacept Novel co-stimulation blocker Establishing a new developed to replace immunotherapy paradigm cornerstone therapy in solid for the treatment of cancer A new cytotoxic designed to organ transplantation overcome resistance Saxagliptin Dapagliflozin Apixaban Bringing a new choice Providing a new insulin- Predictable and reliable to the management of diabetes independent mechanism for anticoagulant with a wider – driven by the partnership of improved outcomes in therapeutic window than Bristol-Myers Squibb overweight and obese current standard of care and AstraZeneca diabetes patients Not for promotional use 22
  23. 23. Saxagliptin: DPP4 Inhibition – An Emerging Mechanism for Diabetes Treatment Once a day, oral route of administration Weight neutral and low incidence of hypoglycemia In clinical trials, safety profile comparable to placebo Prolonged glycemic control at low dose due to: – Highly potent inhibition of DPP4 – Sustained binding to DPP4 active site Fixed-dose combinations facilitated by: – Unique formulation – Efficacy at low dose Not for promotional use 23
  24. 24. Saxagliptin + Metformin Show Improved HbA1c Reductions at Week 24 Adjusted Change From Baseline Difference in Adjusted Change from Baseline vs Placebo + Metformin 0.4 0.2 % Change in HbA1c 0 -0.2 -0.83 -0.72 -0.73 -0.4 -0.6 * -0.8 * * -1 SAXA 10mg SAXA 5mg SAXA 2.5mg PBO + MET + MET + MET + MET (N = 180) (N = 186) (N = 186) (N = 175) * p<0.0001 Bars indicate 95% two-sided confidence interval two- Phase III Study -014, ADA, June 2007 Not for promotional use 24
  25. 25. Saxagliptin Registrational Program NDA submission targeted for 1H 08 Target indications – Monotherapy – Add-on combination therapy (metformin, TZD, sulfonylurea) – Initial combination therapy with metformin Phase III data presentations – ADA, June 2008 – EASD, Sept 2008 Not for promotional use 25
  26. 26. Building Pipelines Within Products: Full Development Programs Ipilimumab Belatacept Novel co-stimulation blocker Establishing a new developed to replace immunotherapy paradigm cornerstone therapy in solid for the treatment of cancer A new cytotoxic designed to organ transplantation overcome resistance Saxagliptin Dapagliflozin Apixaban Bringing a new choice Providing a new insulin- Predictable and reliable to the management of diabetes independent mechanism for anticoagulant with a wider – driven by the partnership of improved outcomes in therapeutic window than Bristol-Myers Squibb overweight and obese current standard of care and AstraZeneca diabetes patients Not for promotional use 26
  27. 27. Properties of an Ideal Anticoagulant Apixaban target profile Properties Benefits Orally active Ease of administration Obviates need for overlap with Rapid onset of action a parenteral anticoagulant No food or drug interactions Simplified dosing No routine coagulation Predictable anticoagulant effect monitoring Safe in patients with renal Extra-renal clearance insufficiency Simplifies management in case Rapid offset of action of bleed or need for intervention Treatment benefit outweighs Optimal benefit/risk profile risk Not for promotional use 27
  28. 28. Apixaban Demonstrated Greater Efficacy in Preventing VTE / Death Than Standard of Care (Phase II Study) 40 Venous 35 Thromboembolism (VTE) / Total Bleeding Death 30 % of Patients 25 20 15 10 5 0 QD BID QD BID QD BID QD BID QD BID QD BID Enox Warf Enox Warf Daily Dose: 5 10 20 5 10 20 (mg) Apixaban Apixaban BID dosing consistently produced lower rates of VTE/death compared with QD dosing with comparable bleeding rates Phase II VTE Prevention Study: APROPOS (CV185010), ASH December 2006 Not for promotional use 28
  29. 29. Apixaban Clinical Development: Pursuing Multiple Indications Simultaneously Indication Phase Trial N VTE prevention (knee replacement) III ADVANCE-1 3,000 VTE prevention (knee replacement) III ADVANCE-2 3,000 VTE prevention (hip replacement) III ADVANCE-3 4,000 VTE prevention (medical) III ADOPT 6,500 Stroke prevention in AF (vs. warfarin) III ARISTOTLE 15,000 Stroke prevention in AF (vs. aspirin) III AVERROES 5,600 VTE treatment III In Final Planning Acute Coronary Syndrome II APPRAISE-1 1,800 VTE prevention in cancer II ADVOCATE 160 VTE – venous thromboembolism Not for promotional use 29
  30. 30. Building Pipelines Within Products: Full Development Programs Ipilimumab Belatacept Novel co-stimulation blocker Establishing a new developed to replace immunotherapy paradigm cornerstone therapy in solid for the treatment of cancer A new cytotoxic designed to organ transplantation overcome resistance Saxagliptin Dapagliflozin Apixaban Bringing a new choice Providing a new insulin- Predictable and reliable to the management of diabetes independent mechanism for anticoagulant with a wider – driven by the partnership of improved outcomes in therapeutic window than Bristol-Myers Squibb overweight and obese current standard of care and AstraZeneca diabetes patients Not for promotional use 30
  31. 31. Execution of BMS Biologics Strategy Adnexus Ipilimumab Devens Bulk Erbitux Manufacturing (Cancer) (Cancer) Domantis Belatacept Orencia Syracuse Therapeutic (Solid Organ (Rheumatoid Transplant) Area Biology Third Party Arthritis) Angiocept Manufacturers (Cancer) Anti-CD137 (Cancer) Not for promotional use 31
  32. 32. Adnexus: The Opportunity Novel fibronectin-based protein therapeutics platform Distinct from conventional and domain antibodies Freedom to operate in existing MAb space E. coli-based production may result in lower cost of goods Improved Discovery cycle time and associated lower cost per development candidate Ability to bind two targets simultaneously Adnexus’ lead product, Angiocept, in Phase II Not for promotional use 32
  33. 33. Angiocept Potent and specific antagonist of VEGFR-2 Comparable or better activity than Avastin in animal models Encouraging clinical profile – Generally well tolerated – Favorable and consistent pharmacokinetic profile – Clinical observations of VEGFR-2 blockade – Stable disease demonstrated in several patients with advanced, refractory malignancies Transitioned to Phase II Not for promotional use 33
  34. 34. 2008 Key Data Flow Lupus: ACR, Oct 2008 Orencia Early RA: ACR, Oct 2008 RA Prevention: EULAR, June 2008 Sprycel Solid Tumors: data available 1H 2008 Erbitux Lung: ASCO, June 2008 ACTIVE-A data available: 2H 2008 Plavix CURRENT data available: 2H 2008 MBC -046 survival data: ASCO Breast, Sept 2008 Ixempra MBC -048 survival data: SABCS, Dec 2008 Ipilimumab Metastatic melanoma: ASCO, June 2008 Belatacept Ph III data available: 4Q 2008 Ph III data: ADA, June 2008 Saxagliptin Ph III data: EASD, Sept 2008 Dapagliflozin Ph IIb data: ADA, June 2008 Ph II ACS data available: 3Q 2008 Apixaban Ph III VTE prevention data: ASH, Dec 2008 Not for promotional use 34

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