Outlook for U.S. Business for 2009（2.15MB）

Outlook for U.S. Business for 2009（2.15MB）

Daiichi Sankyo, Inc. (DSI)
Outlook for U.S. Business for 2009
Nov. 7th, 2007
Joseph P. Pieroni
President and CEO
Daiichi Sankyo, Inc.
Largest Pharmaceutical markets
Annual Sales (US$ billions)
Japan
9%
$274.4
$300
Others
12%
$250
U.S.
47%
$200
EU
32%
$150
$56.7
$100
$31.9
$34.0
$20.5
$20.5
$50
$16.3
$15.5
$0
U.S.
page 1
Source: IMS
Japan
Germany
France
UK
Italy
Spain
Canada
Daiichi Sankyo, Inc. - U.S. Organization
Commercial
Operations
(Parsippany, NJ)
(Home Office: 340)
Sales Force
(1,350)
(# employees)
page 2
Clinical & Regulatory
(Edison, NJ)
(260)
Daiichi Sankyo, Inc. – Product Portfolio
Product
Product
Therapeutic
Therapeutic Category
Category
Net
NetSales
Sales
FY
FY2007
2007
($
($million)
million)
Anti-Hypertension
$756
Dyslipidemia
$205
Anti-hypertensive
$28
Dry Mouth Syndrome
$32
$1,021
$1,021
Total
Total
page 3
Source: Daiichi Sankyo
page 4
ARB Market
Benicar new prescription share continues to grow in ARB Market
Mono & Combo New Rx Share
45%
Mono & Combo NRx Market Share
40.07%
DIOVAN / DIOVAN HCT
40%
35%
COZAAR / HYZAAR
30%
25%
20.41%
20%
BENICAR / BENICAR HCT 16.64%
AVAPRO / AVALIDE
15%
BENICAR
HCT Launch
10%
ATACAND / ATACAND HCT
5% MICARDIS / MICARDIS HCT
page 5
Source: IMS National Prescription Audit ( Weekly Data)
9/14/07
10/12/07
7/20/07
5/25/07
3/30/07
2/2/07
12/8/06
10/13/06
8/18/06
6/23/06
4/28/06
3/3/06
1/6/06
11/11/05
9/16/05
7/22/05
5/27/05
4/1/05
2/4/05
12/10/04
10/15/04
8/20/04
6/25/04
4/30/04
3/5/04
1/9/04
11/14/03
9/19/03
7/25/03
5/30/03
4/4/03
2/7/03
12/13/02
10/18/02
8/23/02
6/28/02
5/3/02
TEVETEN / TEVETEN HCT
0%
Product Pipeline
Products in late stage development
Development
DevelopmentStage
Stage
Product
Product
Therapeutic
TherapeuticClass
Class
Key
Key Characteristics
Characteristics
NDA Approved
Azor
Hypertension
highly effective olmesartan
combined with amlodipine
WelChol*
Diabetes
only product to reduce both
cholesterol and glucose
prasugrel**
Acute Coronary
Syndrome
head to head trial versus
Plavix
NDA
*FDA approval expected in November 2007
**FDA filing by year-end
page 6
New Product Launches
Q1
Q1
FY2007
FY2007
Q2
Q2
Q3
Q3
Q4
Q4
Q1
Q1
FY2008
FY2008
Q2
Q2
Q3
Q3
Q4
Q4
Q1
Q1
FY2009
FY2009
Q2
Q2
Azor
Azor
Amlodipine
Amlodipine- olmesartan
olmesartan
WelChol
WelChol
diabetes
diabetes
Forest
Forest
Benicar
Benicar
co-promotion
co-promotion
ends
ends
Sales
Force
Expansion
page 7
900
900
1,350
1,350
prasugrel
prasugrel
1,550
1,550
2,200
2,200
Q3
Q3
Q4
Q4
The AZOR Opportunity
amlodipine Market before patent expiration
17 million prescriptions
$1.6 billion
43 million prescriptions
$2.7 billion
amlodipine-benazepril
Only successful fixed-dose combination
amlodipine
Most successful anti-hypertensive
page 9
IMS.Health December 2006
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
AZOR vs. amlodipine
Mean Change in BP at Week 8
amlodipine
5 mg
0
BENICAR
olmesartan
40 mg
AZOR
amlodipine 5mg /
olmesartan 40 mg
-5
mm Hg
-9
-10
-10
-15
-16
-15
-16
-20
-25
An additional
-30
reduction
67%
Systolic BP
page 11
-25
Diastolic BP
Data on File. Daiichi Sankyo, Inc. AZOR package insert
AZOR vs. amlodipine
Mean Change in BP at Week 8
amlodipine
10 mg
0
BENICAR
olmesartan
40 mg
AZOR
amlodipine 10 mg /
olmesartan 40 mg
mm Hg
-5
-10
-10
-13
-16
-15
-19
-20
-20
-25
An additional
-30
53%
Systolic BP
page 12
-30
reduction
Diastolic BP
Data on File. Daiichi Sankyo, Inc. AZOR package insert
AZOR vs. amlodipine
Percentage of Patients
Placebo-subtracted Incidence of Edema
30.0
54%
25.0
reduction in
Edema
24.5%
20.0
15.0
13.9%
10.0
11.2%
5.0
0.0
amlodipine 10mg
page 13
Data on File. Daiichi Sankyo, Inc. AZOR package insert
Azor 10/20mg
Azor 10/40mg
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%
-15.30%
ACEIs
12%
Diuretics
CCBs
ARBs
1.7%
34%
-27.90%
Diuretics
3%
BBs*
71%
Norvasc
Lotrel
CCBs
27%
10%
Total Sales = $18.4 B
page 14
IMS.Health December 2006
-16.5%
ARBs*
14.7%
Lotrel
14.3%
ACEIs*
Anti-hypertensive Market
Polytherapy Growing in hypertension therapy
% of Patients on Polytherapy
100%
80%
60%
40%
20%
0%
75%
74%
48%
45%
52%
Stage 1
2004
82%
Stage 2
2005
2006
Physicians using more combination therapy as a first line agent and are quicker to switch to
combination therapy for patients not at goal
IMS,.Health NPA data 2004-2006
page 15
Azor vs. Benicar
Patient Targets
•Stage 1
•Stage 1
•Predominantly
Stage 2
•Stage 2
-More Severe
-Difficult to treat
•Typically
Complicated
•amlodipine & Lotrel
Patients
page 16
Benicar, Azor Targets
Benicar,
Benicar
HCT
ARB
page 17
ARB/HCT
AZOR
Amlo
Lotrel
Exforge
Product Positioning
For
Azor is the
that
because
so that
page 18
patients that need greater blood pressure control
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 19
Cholesterol
New
Cholesterol
+
Diabetes
page 20
Markets for Cholesterol and Diabetes are growing
HC Prescription Trends
Diabetes Prescription Trends
224.4
200.6
200
200
180.9
160.8
141.7
150
TRx Vol (M)
TRx Vol (M)
150
100
50
121.3
100
98.5
103.3
128.2
110.6
50
0
0
MAT 2003
MAT 2004
MAT 2005
MAT 2006
MAT 2007
page 21 IMS Health, National Prescription Audit, 2007
MAT 2003
MAT 2004
MAT 2005
MAT 2006
MAT 2007
Aggressive Goals for both Cholesterol and Diabetes
Cholesterol
Diabetes
2007 NCEP Guidelines
2007 ADA Guidelines
LDL-C goal
In high-risk patients
(<100 mg/dL)
Current therapeutic option for
patients with CHD (<70 mg/dL):
Especially patients with diabetes
page 22
Patients in general
(<7% A1C)
Current goal for
individual patients (<6% A1C):
As close to normal as possible
Patients Are not at Goal
Percent of people not at Goal in U.S.
Cholesterol
>50%
page 23
Diabetes
67%
Cholesterol Treatment
Increase in Combination therapy
page 24
Diabetes Treatment
Increase in Combination Therapy
page 25
Welchol Studies for Glucose lowering
Real-World Study Design
Metformin
Insulin
Sulfonylureas
+
Welchol
Metformin
Insulin
Sulfonylureas
+
Any Other AD
Medications
page 26
+
Welchol
Welchol produced Consistent Reductions in A1C
A1C Reduction (%)
Metformin
Based*
Sulfonylurea
Based**
Insulin
Based†
-0.05
-0.15
-0.25
-0.35
-0.45
-0.55
-0.65
-0.54
-0.55
-0.5
*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 1581.
page 27
Efficacy Expectations in Diabetes Therapy
Results of glucose lowering from recently published trials
in similar patient populations
JanuviaTM Byetta®
Avandia®
Welchol®
A1C Reduction (%)
0
-0.2
-0.4
‡
-0.6
†
*
**
-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. 2007 Jun;24(6):626-34
**Pooled analysis (WEL-301, WEL-302, WEL-303), Data on file, Daiichi Sankyo, Inc.
page 28
Adverse Events Concerns with Diabetic Therapy
Not Associated With Welchol™
Typical Adverse Events
page 29
Welchol™
Increased Hypoglycemia
NO
Weight Gain
NO
Contraindications (CHF, Kidney)
NO
Edema
NO
CYP450 Interactions
NO
A1C
+ LDL-C
Two Goals One Therapy
page 30
Product Opportunities
Achieve
AchieveBenicar
Benicarsales
sales
of
of $1
$1billion
billion
With patent expiration of Norvasc,
Benicar and Diovan will be the major
antihypertensive drugs in U.S.
Capture
Capturesignificant
significantshare
shareof
of
ARB-amlo
combo
market
ARB-amlo combo market
with
withAzor
Azor
amlo olmesartan and amlo valsartan
(Exforge-Novartis) will create a new
market for ARB-amlodipine combos
Significantly
Significantlyincrease
increase
Welchol
sales
with
Welchol sales withnew
new
diabetes
indication
diabetes indication
Make
Makeprasugrel
prasugrelaa
blockbuster
blockbuster
page 31
Novel approach to the treatment of
diabetes plus lipid lowering
Success with prasugrel will make
DSI a Top-Tier CV Company in U.S.
Daiichi Sankyo, Inc.
Mid-Term Sales
Net Sales ($ Millions)
$1,500
New
Products
$1,000
Current
Products
$500
$0
2006
page 32
2007
2008
2009
U.S. Cardiovascular Market
Total
TotalCardiovascular
CardiovascularMarket
Market(2006)
(2006)
$50
Billion
$50 Billion
Hypertension
Hypertension
$18.5
$18.5BN
BN
Hyperlipidemia
Hyperlipidemia
$21.6
$21.6BN
BN
Anti-Platelet
Anti-Platelet
$4.1
$4.1BN
BN
Anti-Coagulant
Anti-Coagulant
$3.1
$3.1BN
BN
Lotrel:
Lotrel:$1.5
$1.5BN
BN
Lipitor:
Lipitor:$8.6
$8.6BN
BN
Plavix:
Plavix:$2.9
$2.9BN
BN
Lovenox:
Lovenox:$2.1
$2.1BN
BN
Toprol
ToprolXL:
XL: $1.7
$1.7BN
BN
Crestor:
Crestor:$1.3
$1.3BN
BN
prasugrel
prasugrel
DU
DU176b
176b
Diovan:
Diovan:$2.3
$2.3BN
BN
Cozaar:
Cozaar:$1.4
$1.4BN
BN
Benicar:
Benicar:$831
$831MM
MM
Vytorin:
Vytorin:$1.9
$1.9BN
BN
Zetia:
Zetia:$1.5
$1.5BN
BN
Welchol:
Welchol:$200
$200MM
MM
page 33
Source: NCI Analysis; IMS NPA Sales 2006
Long-term Strategic Objectives
Become
BecomeLeader
Leaderin
in
Hypertension
Hypertension
Become
BecomeTop
Top–Tier
–Tier
Cardiovascular
Company
Cardiovascular Company
Produce
ProduceSignificant
SignificantProfit
Profit
growth
growthfor
forDaiichi
DaiichiSankyo
Sankyo
page 34
•Achieve
•Achieve sales
salesof
of$2
$2billion
billion with
with
Benicar
Benicarfranchise
franchiseand
andAzor
Azor
•• Hypertension
Hypertension--Benicar,
Benicar,Azor
Azor
•• Antiplatelet
Antiplateletmarket
market --prasugrel
prasugrel
•• Anti-coagulant
Anti-coagulantmarket
market --DU
DU176b
176b
••Achieve
Achievesignificant
significantlocal
localoperating
operating
profit
profitfrom
from2009
2009onward
onward
Contact address regarding this material
DAIICHI SANKYO CO., LTD.
Corporate Communications Department
TEL: +81-3-6225-1126
FAX: +81-3-6225-1132
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