Daiichi Sankyo, Inc. (DSI)

Transcription

1 Daiichi Sankyo, Inc. (DSI) Outlook for U.S. Business for 2009 Nov. 7 th, 2007 Joseph P. Pieroni President and CEO Daiichi Sankyo, Inc.

2 Largest Pharmaceutical markets $300 $274.4 Annual Sales (US$ billions) Others 12% Japan 9% $250 $200 U.S. 47% $150 EU 32% $100 $56.7 $50 $31.9 $34.0 $20.5 $20.5 $16.3 $15.5 $0 U.S. Japan Germany France UK Italy Spain Canada page 1 Source: IMS

3 Daiichi Sankyo, Inc. - U.S. Organization Commercial Operations (Parsippany, NJ) (Home Office: 340) Sales Force (1,350) Clinical & Regulatory (Edison, NJ) (260) (# employees) page 2

4 Daiichi Sankyo, Inc. Product Portfolio Product Therapeutic Category Anti-Hypertension Net Sales FY 2007 ($ ($ million) $756 Dyslipidemia $205 Anti-hypertensive $28 Dry Mouth Syndrome $32 Total Total $1,021 $1,021 page 3 Source: Daiichi Sankyo

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6 ARB Market Benicar new prescription share continues to grow in ARB Market 45% Mono & Combo New Rx Share 40% DIOVAN / DIOVAN HCT 40.07% 35% 30% COZAAR / HYZAAR 25% 20% 15% 10% AVAPRO / AVALIDE BENICAR / BENICAR HCT ATACAND / ATACAND HCT BENICAR HCT Launch 20.41% 16.64% 5% MICARDIS / MICARDIS HCT 0% TEVETEN / TEVETEN HCT 10/12/07 5/3/02 6/28/02 8/23/02 10/18/02 12/13/02 2/7/03 4/4/03 5/30/03 7/25/03 9/19/03 11/14/03 1/9/04 3/5/04 4/30/04 6/25/04 8/20/04 10/15/04 12/10/04 2/4/05 4/1/05 5/27/05 7/22/05 9/16/05 11/11/05 1/6/06 3/3/06 4/28/06 6/23/06 8/18/06 10/13/06 12/8/06 2/2/07 3/30/07 5/25/07 7/20/07 9/14/07 page 5 Source: IMS National Prescription Audit ( Weekly Data) Mono & Combo NRx Market Share

7 Product Pipeline Products in late stage development Development Stage Product Therapeutic Class Key Characteristics NDA Approved Azor Hypertension highly effective olmesartan combined with amlodipine NDA WelChol* prasugrel** Diabetes Acute Coronary Syndrome only product to reduce both cholesterol and glucose head to head trial versus Plavix *FDA approval expected in November 2007 **FDA filing by year-end page 6

8 New Product Launches FY2007 Q1 Q1 Q2 Q2 Q3 Q3 Q4 Q4 Azor Azor Amlodipine Amlodipine - - olmesartan olmesartan FY2008 Q1 Q1 Q2 Q2 Q3 Q3 Q4 Q4 FY2009 Q1 Q1 Q2 Q2 Q3 Q3 Q4 Q4 WelChol WelChol diabetes diabetes Forest Forest Benicar Benicar co-promotion co-promotion ends ends prasugrel prasugrel Sales Force Expansion ,350 1,550 2,200 page 7

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10 The AZOR Opportunity amlodipine Market before patent expiration 43 million prescriptions $2.7 billion amlodipine Most successful anti-hypertensive 17 million prescriptions $1.6 billion amlodipine-benazepril Only successful fixed-dose combination page 9 IMS.Health December 2006

11 Amlodipine + ARB Combination Market amlodipine / valsartan (Novartis) -Number 1 ARB combined with amlodipine - Launched June 2007 amlodipine / olmesartan (Daiichi Sankyo) -Fastest growing ARB combined with amolipine -Launched October 2007 page 10

12 AZOR vs. amlodipine Mean Change in BP at Week 8 0 amlodipine 5 mg BENICAR olmesartan 40 mg AZOR amlodipine 5mg / olmesartan 40 mg mm Hg Systolic BP -16 An additional 67% reduction Diastolic BP page 11 Data on File. Daiichi Sankyo, Inc. AZOR package insert

13 AZOR vs. amlodipine Mean Change in BP at Week 8 0 amlodipine 10 mg BENICAR olmesartan 40 mg AZOR amlodipine 10 mg / olmesartan 40 mg -5 mm Hg Systolic BP An additional 53% reduction -30 Diastolic BP page 12 Data on File. Daiichi Sankyo, Inc. AZOR package insert

14 AZOR vs. amlodipine Placebo-subtracted Incidence of Edema Percentage of Patients % 54% reduction in Edema 13.9% 11.2% 0.0 amlodipine 10mg Azor 10/20mg Azor 10/40mg page 13 Data on File. Daiichi Sankyo, Inc. AZOR package insert

15 Anti-hypertensive Market ARBs, Norvasc and Lotrel ARBs and Lotrel -account for 71% of market - fastest growing classes 2006 Anti-hypertensive $ sales Sales Growth (2005 vs. 2006) BBs 14% Diuretics 3% ACEIs 12% Norvasc CCBs 27% 71% Lotrel 10% ARBs 34% % % Diuretics CCBs BBs* ARBs* Lotrel -16.5% ACEIs* 1.7% 14.7% 14.3% Total Sales = $18.4 B page 14 IMS.Health December 2006

16 Anti-hypertensive Market Polytherapy Growing in hypertension therapy % of Patients on Polytherapy 100% 80% 60% 40% 20% 0% 48% 45% 52% Stage 1 Stage Physicians using more combination therapy as a first line agent and are quicker to switch to combination therapy for patients not at goal 74% 75% 82% page 15 IMS,.Health NPA data

17 Azor vs. Benicar Patient Targets Stage 1 Stage 1 Stage 2 Predominantly Stage 2 -More Severe -Difficult to treat Typically Complicated amlodipine & Lotrel Patients page 16

18 Benicar, Azor Targets Benicar, Benicar HCT AZOR ARB ARB/HCT Amlo Lotrel Exforge page 17

19 Product Positioning For patients that need greater blood pressure control Azor is the that because so that combination of the most-prescribed CCB, amlodipine, and the most potent ARB, olmesartan provides superior blood pressure reduction (up to 40 mm Hg) across many patient types it targets two distinct pathways of hypertension through calcium channel blockade and angiotensin II blockade patients feel reassured that they can get BP control with the convenience of a single pill. page 18

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21 Cholesterol New Cholesterol + Diabetes page 20

22 Markets for Cholesterol and Diabetes are growing HC Prescription Trends Diabetes Prescription Trends TRx Vol (M) TRx Vol (M) MAT 2003 MAT 2004 MAT 2005 MAT 2006 MAT MAT 2003 MAT 2004 MAT 2005 MAT 2006 MAT 2007 page 21 IMS Health, National Prescription Audit, 2007

23 Aggressive Goals for both Cholesterol and Diabetes Cholesterol 2007 NCEP Guidelines LDL-C goal In high-risk patients (<100 mg/dl) Diabetes 2007 ADA Guidelines Patients in general (<7% A1C) Current therapeutic option for patients with CHD (<70 mg/dl): Especially patients with diabetes Current goal for individual patients (<6% A1C): As close to normal as possible page 22

24 Patients Are not at Goal Percent of people not at Goal in U.S. Cholesterol >50% Diabetes 67% page 23

25 Cholesterol Treatment Increase in Combination therapy page 24

26 Diabetes Treatment Increase in Combination Therapy page 25

27 Welchol Studies for Glucose lowering Real-World Study Design Metformin Insulin Sulfonylureas + Welchol Metformin Insulin Sulfonylureas + Any Other AD Medications + Welchol page 26

28 Welchol produced Consistent Reductions in A1C Metformin Based* Sulfonylurea Based** Insulin Based A1C Reduction (%) *Bays H et al. Abstracts of the 16th Annual AACE Meeting & Clinical Congress; April 11-15, 2007; Seattle, WA. Abstract 204:18. **Fonseca VA et al. Abstracts of the 16th Annual AACE Meeting & Clinical Congress; April 11-15, 2007; Seattle, WA. Abstract 409:10. Goldberg RB and Truitt K. Presented at: AHA Scientific Sessions 2006; November 12-15, 2006; Chicago, IL. Poster page 27

29 Efficacy Expectations in Diabetes Therapy Results of glucose lowering from recently published trials in similar patient populations 0 Januvia TM Byetta Avandia Welchol A1C Reduction (%) * ** -0.8 Januvia (sitagliptin) Package Insert, April 2007 Byetta (exenatide) Package Insert, September 2007 *Home, PD et al. Rosiglitazone RECORD study: glucose control outcomes at 18 months. Diabet Med Jun;24(6): **Pooled analysis (WEL-301, WEL-302, WEL-303), Data on file, Daiichi Sankyo, Inc. page 28

30 Adverse Events Concerns with Diabetic Therapy Not Associated With Welchol Typical Adverse Events Welchol Increased Hypoglycemia Weight Gain Contraindications (CHF, Kidney) Edema CYP450 Interactions NO NO NO NO NO page 29

31 A1C + LDL-C Two Goals One Therapy page 30

32 Product Opportunities Achieve Benicar sales of of $1 $1 billion With patent expiration of Norvasc, Benicar and Diovan will be the major antihypertensive drugs in U.S. Capture significant share share of of ARB-amlo combo market with with Azor Azor amlo olmesartan and amlo valsartan (Exforge-Novartis) will create a new market for ARB-amlodipine combos Significantly increase Welchol sales sales with with new new diabetes indication Novel approach to the treatment of diabetes plus lipid lowering Make prasugrel a blockbuster Success with prasugrel will make DSI a Top-Tier CV Company in U.S. page 31

33 Daiichi Sankyo, Inc. Mid-Term Sales Net Sales ($ Millions) $1,500 $1,000 $500 New Products Current Products $ page 32

34 U.S. Cardiovascular Market Total Total Cardiovascular Cardiovascular Market Market (2006) (2006) $50 $50 Billion Billion Hypertension Hypertension $18.5 $18.5 Hyperlipidemia Hyperlipidemia $21.6 $21.6 Anti-Platelet Anti-Platelet $4.1 $4.1 Anti-Coagulant Anti-Coagulant $3.1 $3.1 Lotrel: Lotrel: $1.5 $1.5 Lipitor: Lipitor: $8.6 $8.6 Plavix: Plavix: $2.9 $2.9 Lovenox: Lovenox: $2.1 $2.1 Toprol Toprol XL: XL: $1.7 $1.7 Diovan: Diovan: $2.3 $2.3 Cozaar: Cozaar: $1.4 $1.4 Crestor: Crestor: $1.3 $1.3 Vytorin: Vytorin: $1.9 $1.9 Zetia: Zetia: $1.5 $1.5 prasugrel prasugrel DU DU 176b 176b Benicar: Benicar: $831 $831 MM MM Welchol: Welchol: $200 $200 MM MM page 33 Source: NCI Analysis; IMS NPA Sales 2006

35 Long-term Strategic Objectives Become Leader Leader in in Hypertension Achieve sales sales of of $2 $2 billion billion with with Benicar franchise and and Azor Azor Become Top Top Tier Tier Cardiovascular Company Hypertension --Benicar, Azor Azor Antiplatelet market market --prasugrel Anti-coagulant market market --DU DU 176b 176b Produce Significant Profit Profit growth for for Daiichi Daiichi Sankyo Achieve significant local local operating profit profit from from onward page 34

36 Contact address regarding this material DAIICHI SANKYO CO., LTD. Corporate Communications Department TEL: FAX: Each numerical value regarding the future prospect in this material is derived from our judgment and assumptions based on the currently available information and may include risk and uncertainty. For this reason, the actual performance data, etc. may differ from the prospective value. page 38