Growth toward a World-class Pharmaceutical Company

Growth toward a World-class
Pharmaceutical Company
Yasuchika Hasegawa, President
Takeda Pharmaceutical Company Limited
November 5, 2008
2008.5
Update on ongoing NDA Reviews by US FDA
SYRSYR-322 (Diabetes)
PDUFA date: October 27
Postponed
Updated PDUFA date: TBD
TAKTAK-390MR (GERD)
PDUFA date: October 31
Postponed
Updated PDUFA date: January 31, 2009
TMXTMX-67 (Gout)
November 24: FDA Advisory Committee
PDUFA date：
date： January 18, 2009
1
2006-2010 Medium-term Plan
Growth toward a WorldWorld-class
Pharmaceutical Company
Enhancement of
R&D pipeline
Ethical drugs Sales (Consolidated basis)
FY2015 Yen 2 trillion
FY2010 Yen 1.4 trillion
Improvement of
geographical coverage
Recruitment and development
of highhigh-caliber people
Taking full advantage of Takeda’
Takeda’s characteristics and strengths
Establish and execute precise strategies with a longlong-term focus
Pursue improved productivity and efficiency throughout the organization
organization
Establish strong collaborative teams that cross both internal and
and external boundaries
2
Maximization of TPNA/TAP Integration Effects
Completed Building of Appropriate and Effective Structure
on Every Function Except for IT system
Streamlining of marketing, development and
administration functions
Cost synergies of ¥40 billion are expected
over the 3 years following the integration of TAP
Sales maximization of marketed products and
products under FDA review
($MM)
<Actos Sales in U.S.>
Actos (Diabetes)
Prevacid (GERD)
Amitiza (Constipation)
Rozerem (Insomnia)
SYRSYR-322
TAKTAK-390MR
TMXTMX-67
(Estimate)
3
Sales Growth of VELCADE
Sales in U.S.
First Half, FY2008: $190MM (+42.9%)
Full Year, FY2008: Estimate about 40% growth compared to the previous year (FY2007: $290MM)
Royalty revenue from J&J derived from its sales exex-U.S
First Half, FY2008: $63MM (+75%)
Full Year, FY2008: Estimate about 50% growth compared to the previous year (FY2007: $88MM)
($MM)
4
Forecasts for FY2008 and Results of 1st Half
Net Sales
Net sales of
ethical drugs
(% of net sales)
R&D expenses
Results of FY07
1st Half results for FY08
Forecasts for FY08
Yen 1,374.8 billion (+5.3%)
Yen 807.1 billion (+13.9%)
Yen 1,560.0 billion (+ 13.5%)
Yen 1,210.2 billion (+5.8%)
Yen 728.2 billion (+15.7%)
Yen 1,400.0 billion (+ 15.7%)
(88.0%)
（90.2%）
90.2%）
(89.8%)
Yen 275.8 billion (+42.7%)
Yen 321.1 billion*1(+199.2%)
Yen 470.0 billion*1（+70.4%）
+70.4%）
(% of net sales)
(20.1%)
(39.8%)
（30.1%）
30.1%）
Operating Income
Yen 423.1 billion (- 7.7%)
Yen 85.0 billion (-67.9%)
Yen 270.0 billion (- 36.2%)
(% of net sales)
(30.8%)
(10.5%)
(17.3%)
Net income
Yen 355.5 billion (+5.9%)
Yen 71.8 billion ((- 67.1%)
Yen 195.0 billion (- 45.1%)
(% of net sales)
(25.9%)
(8.9%)
（12.5%）
12.5%）
Yen 391.48 (+9.7%)
Yen 234.30 (- 0.5%)
Yen 421.23 (+ 7.6%)
*2
EPS
*1 R&D expense: Including one-off amortization cost of 166.2 billion yen
*2 EPS: Excluding extraordinary gains and losses and extraordinary factors related to corporate acquisitions and others
5
Strengthening of Pipeline
Products planned for NDA submission by FY2010
SYR-322 (Diabetes): U.S. (Filed Dec 07), Jpn (Filed Sep 08), EU (P-III)
SYR-322/Actos FDC (Diabetes): U.S. (Filed Sep 08)
TAK-390MR (GERD): U.S. (Filed Dec 07)
TAK-375 (Insomnia): Jpn (Filed Feb 08)
TMX-67 (Gout): U.S. (Filed Dec 04, Submitted additional data in July 08)
Vectibix (Progressive and relapse cancer of the colon and rectum): Jpn (Filed Jun 08)
TAK-491 (Hypertension): U.S. (P-III), EU (P-III) Hematide (Chronic kidney disease related anemia): U.S. (P-III), EU (P-III)
Lu AA21004 (Mood and anxiety disorders): U.S. (P-III),
AMG706 (Progressive non-small cell lung cancer): U.S. (P-III), EU (P-III), Jpn (P-III)
ATL-962 (Obesity): Jpn (P-II)
SYR-472 (Diabetes): U.S. (P-II), EU (P-II)
Acceleration of inin-house R&D
LifeLife-cycle management
Strategic alliances
6
Accelerating Vision of becoming a Top 3
Global Oncology Company (1)
Superior R&D pipeline from global research bases
Takeda San Francisco
Takeda
Cambridge
Millennium:
The Takeda Oncology Company
TPC
Takeda San Diego
Takeda Singapore
7
Accelerating Vision of becoming a Top 3
Global Oncology Company (2)
Aiming for earliest launch of superior oncology drugs
Maximization of synergy effects
in each function of both companies
Research
Takeda Group
Development
Marketing
Millennium:
The Takeda
Oncology Company
+
Further improvement of pipeline in oncology area
8
Accelerating Vision of becoming a Top 3 Global Oncology Company (3)
Broadened pipeline in oncology
Preclinical
Phase I
Phase II
Phase III
Filed
Vectibix *
* cancer
Progressive Vectibix
and relapse
Progressive
and
relapse
cancer
of the colon
and
rectum
of the colon and rectum
TAK-701/HuL2G7 *
TAK-701/HuL2G7
*
Cancer
Cancer
TAK-700
TAK-700
Prostate
cancer
Prostate cancer
VELCADE
VELCADE
Several
tumors
Several tumors
AMG706 *
AMG706
* cell
Progressive
non-small
Progressive
non-small cell
lung cancer
lung cancer
TAK-799/TRM-1 *
TAK-799/TRM-1
*
Cancer
Cancer
CBP501 *
CBP501
*
Malignant
mesothelioma,
Malignant
mesothelioma,
Lung cancer
Lung cancer
MLN0518
MLN0518
Glioblastoma
Glioblastoma
VELCADE
VELCADE
Follicular
NHL
Follicular NHL
・
・
・
・
・
・
・
・
・
TAK-285
TAK-285
Solid
cancer
Solid cancer
Vectibix *
Vectibix
*
Head and
neck cancer
Head and neck cancer
TAK-683
TAK-683
Prostate
cancer
Prostate cancer
TAK-448
TAK-448
Prostate
cancer
Prostate cancer
TAK-593
TAK-593
Solid
cancer
Solid cancer
AMG655 *
AMG655
*
Advanced
malignancies
Advanced malignancies
MLN2238
MLN2238
Advanced
malignancies
Advanced malignancies
MLN8237 / MLN8054
MLN8237
/ MLN8054
Advanced
malignancies
Advanced malignancies
MLN3897 / MLN3701
MLN3897 / MLN3701
Multiple myeloma
Multiple myeloma
MLN4924
MLN4924
Advanced
malignancies
Advanced malignancies
Takeda
Takeda
* Licensed products
Millennium
Millennium
Amgen
Amgen
9
Improvement of Global Operations Structure
Europe
U.S.
Japan
Takeda Cambridge
TGRD（EU）
Takeda Bio
Development Center
TPEU group
Takeda San Francisco
Millennium
TPNA/TGRD
TPC
Asia
Takeda San Diego
Takeda Singapore
Takeda Pharmaceuticals Asia
Takeda Clinical Research Singapore
Asian subsidiaries
10
Returns to shareholders (1)
<Dividend>
Takeda plans to gradually increase the consolidated dividend payout
payout ratio on earnings
earnings before
amortization of intangible assets associated with the acquisition
acquisition of Millennium
Pharmaceuticals,
Pharmaceuticals, Inc. targeting around 45% in FY2010.
(Yen) 40.1%
41.9%
45.0%
(Payout ratio) 33.2%
30.0%
Yen 168
Yen 176
Yen 128
Yen 106
* On earnings before amortization of intangible assets associated with the acquisition of Millennium
11
Returns to shareholders (2)
<Share buy back>
Takada plans to flexibly buy back shares in order to improve capital
capital
efficiency and further promote returns to shareholders.
Total value of acquisition
Total number of
shares acquired
FY2006
Yen 213.5 billion
28.907 million
FY2007
Yen 128.6 billion
16.497 million
FY2008
Yen 205.5 billion
36.994 million
12
Forward-Looking Statements
This presentation contains forward-looking statements regarding the Company's plans,
outlook, strategies and results for the future. All forward-looking statements are based
on judgments derived from the information available to the Company at this time.
Certain risks and uncertainties could cause the Company's actual results to differ
materially from any projections presented in this presentation. These risks and
uncertainties include, but are not limited to, the economic circumstances surrounding
the Company's business; competitive pressure; relative laws and regulations; product
development programs; and changes in exchange rates.
We assume no obligation to update or reverse any forward-looking statements or other
information contained in this presentation, whether as a result of new information,
future events, or otherwise.
The outlook presented in this presentation is the result of management’s assessment
based upon currently available information, and the actual performance could be
influenced by various risks and uncertainties.