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May 13, 2011Masafumi NogimoriPresident and CEOAstellas Pharma Inc.
Financial Results for FY 2010 Ended March 31, 2011
1
Cautionary Statement Regarding Forward-Looking Information
This material includes forward-looking statements based on assumptions and beliefs in light of the information currently available to management and subject to significant risks and uncertainties. Actual financial results may differ materially depending on a number of factors including adverse economic conditions, currency exchange rate fluctuations, adverse legislative and regulatory developments, delays in new product launch, pricing and product initiatives of competitors, the inability of the company to market existing and new products effectively, interruptions in production, infringements of the company’s intellectual property rights and the adverse outcome of material litigation.
This material contains information on pharmaceuticals (including compounds under development), but this information is not intended to make any representations or advertisements regarding the efficacy or effectiveness of these preparations nor provide medical advice of any kind.
2
Summary of Financial Results for FY2010
2
FY2009 FY2010 Change FY2010Forecasts*
Difference from
Forecasts
Factors(Fluctuation from the previous year)
Ref. OSI Impact(Jul- Mar)
Netsales 974.8 953.9 -20.9 942.0 +11.9 ・Tarceva: 24.4 bln. yen / DPP4 etc.: 6.8 bln. yen
・FX impact: -47.3 bln. yen 31.8
COGCOG ratio
289.229.7%
295.931.0%
+6.7+1.3ppt
・OSI impact: -1.0ppt・Change in product mix: +1.8ppt・FX impact on elimination of unrealized gain: -0.1ppt
0.1
SGAExcluding
R&D SGA ratio
303.631.1%
321.433.7%
+17.8 +2.6ppt
・Amortization of intangible fixed assets (OSI): 16.5 bln. yen
・Amortization of goodwill (OSI): 3.5 bln. yen・Decline in refunds of marketing expenses for Flomax in the US
26.6
R&DR&D ratio
195.520.1%
217.322.8%
+21.7+2.7ppt 206.0 +11.3 ・Increase at OSI: 12.7 bln. yen
・Increase in in-licensing fee 12.7
OPOP ratio
186.419.1%
119.112.5%
-67.2-6.6ppt 124.0 -4.8 [OSI’s OP (before amortization): 12.3 bln. yen]
・FX impact: -8.6 bln. yen -7.7Ordinary income 190.9 115.0 -75.9 122.0 -6.9 ・Decrease in interest income
・Exchange loss -7.7Net
income 122.2 67.6 -54.6 82.0 -14.3 ・Costs related to business integration of OSI・Loss due to the earthquake -8.1
USD 93 yen 86 yen -7 yen 84 yenEUR 131 yen 113 yen -18 yen 112 yen
(Billion yen)
*Revised forecasts at 2Q/FY10 financial results announcement
l Exchange rate (average)
Comprehen-sive income 108.6 24.9 -83.7
3
Other assets(fair value)
1,195
Acquisition cost
3,543
Intangible fixed assets2,815
Goodwill1,107
Balance sheet as of June 30, 2010
-Products sold or approved:$2,024MTo be amortized over periods set for individual products
-In-process R&D: $791MTo be amortized after launches
Amortized over 20 years
Amortization
Accounting Treatment of Business Combination with OSI
Other liabilities (fair value)1,573
Amortization expenses for intangible fixed assets: FY2010 Results (9 months) $193M FY2011 Forecasts (12 months) $268M
Amortization expenses for goodwill: FY2010 Results (9 months) $ 41M FY2011 Forecasts (12 months) $ 55M
Amortization expenses: $ 234M $323M
($ million)
4
Impact of the Eastern Japan Earthquake on Financial Results for FY2010Impact on net sales: Approx. +5.0 billion yen-Tentative increase of channel inventory
due to the earthquake
Impact on operating income: Approx. +3.5 billion yen
-Increase of gross profit resulted from the increase of sales
-Transfer of the fixed costs arising from the suspension of operations of laboratories and factories to the special losses
Special losses: 3.0 billion yen-Costs of repairs resulting from damages
to buildings, machinery and equipment-Fixed costs arising from the suspension
of operations
Recent conditions in the wake of the earthquakeTakahagi, Ibaraki prefecture-Technology Center (producton)Progressing restration of manufacturing facilities.Expect to begin production from October.Expect to restart full operations by the end of the year.
-Chemistry & Technology Development Center (research)Resumed research activities in April. Expect to restart full operations in June.
Nishine Plant, Iwate prefectureResumed full operations on April 6.
Tsukuba, Ibaraki prefecture-Tsukuba Research Center (Miyukigaoka)Resumed normal operations on March 22.
-Tsukuba Biotechnology Research Center (Tokodai)Resumed normal operations on March 16.
Marketing activitiesResumed certain MR activities including gathering safety information from March 22 in the affected regions.
5
2,176
1,936
FY10
FY09
1,678
1,798
FY10
FY09
Japan Europe
Sales by Geographical Area (Local Currency Basis)
Americas
(億円)
543.8
529.2
FY10
FY09
(+2.8%)
Increases in Japan/Americas/Asia, decrease in Europe* Calculated according to locations of sellers
Asia
Decreases due to decline of bulk and royalty income ofFlomax in the US. Favorable sales by Astellas Europe
(-6.7%)
Increases because of OSI contribution, despite decreases due to effects of Prograf generics
(+12.4%)
Increases in the domestic sales, offsetting the impact from NHI drug price revision
Increases due to growth of Prograf and Harnal
(€ million) (Billion yen)
($ million)
33.7
29.9
FY10
FY09
(Billion yen)
(+12.5%)
*Sales in the Japanese market: 525.6 (+3.1%) *Sales through Astellas’ own channel: 1,575 (+12.1%)
*Excluding OSI sales: 1,805 (-6.8%)
6
22.9 25.5
35.1 35.8
22.923.5
1.0
1.4
FY2009 FY2010
Asia
Europe
Americas
Japan
82.386.7 (+5.3% vs PY)
FY2010 Growth rate p Japan: +11%p Americas: +11% (USD)p Europe: +19% (EUR)p Asia: +37% (excl. FX impact)
Market share
Vesicare
p Japan: 49% (Mar. 2011, NHI drug price basis)
p US: 21% (TRx, Week of Apr. 29, 2011)
p Europe: 40% (Feb. 2011, cash basis)
Launched: 66 countries/areas
(Billion yen)
6
7
11.8 12.6
7.5 8.4
1.2
2.4 1.0
1.6
FY2009 FY2010
Funguard/Mycamine
21.6
25.1 (+16.1% vs PY)
Asia
Europe
Americas
Japan
(Billion yen)
7
FY2010 Growth ratep Japan: +7%p Americas: +20% (USD)p Europe: +126% (EUR) p Asia: +66% (excl. FX impact)
Market sharep Japan: 57%
(Mar. 2011, NHI drug price basis in antifungal injection market)
p US: 67% (Feb. 2011, Pt-days share among 3 candin agents )
p Europe: Launched in 24 countries/areas(incl. Middle East and Africa)
p Asia: Launched in 10 countries/areas
Launched: More than 30 countries/areas
88
162.6 (-12.9% vs PY)
186.7
Prograf
FY2010 Growth ratep Japan: +17%p Americas: - 35% (USD)p Europe: + 7% (EUR)p Asia: +22% (excl. FX impact)
Topicsp US
TRx share of generic: 55% (Among total tacrolimus products, Week of Apr. 29, 2011)Cumulative from Apr. 2010 to Mar. 2011: 49.1%
p EuropeSales of Advagraf: €122 millionGeneric tacrolimus: - Confirmed approval in several countries- Launched in Germany, U.K., Netherlands, Portugal,
Slovakia and Switzerland
(Billion yen)
Asia
Europe
Americas
Japan
Export
33.8 39.6
68.1 41.0
65.7
60.6
12.8
14.8
6.2
6.5
FY2009 FY2010
9
35.0 29.6
24.3 21.5
8.69.2
45.6
5.2
FY2009 FY2010
113.9
66.5 (-41.6% vs PY)
Harnal
Asia
Europe
Bulk and Royalties
Japan
(Billion yen)
9
FY2010 Growth Ratep Japan: -15%p Europe: +3% (EUR)p Asia: +12% (excl. FX impact)p Bulk and Royalties: -87% (EUR)
TOCASp Sales in Europe : €123 million (-0.2%)p Europe: Launched in 41 countries/areas
(incl. Middle East and Africa)
p Asia: Launched in 11 countries/areas
10
165
162
120
116
Tarceva
Revenues from the outside of the US market
Revenues from the US market
($ million)
Jul. 2009-Mar. 2010
285(+2%)
279
Jul. 2010-Mar. 2011
p Indications
p Net sales of Tarceva for Jul. 2010-Mar. 2011l Worldwide $ 985MM (+5%)
US $ 388MM (+5%)Outside of the US $ 597MM (+4%)
nTarceva-related revenues
l Non-small cell lung cancer (NSCLC)(locally advanced or metastatic)Ø Approved for 2nd/3rd lineØ Approved for 1st line maintenance in the
US and EU in the first half of 2010l Pancreatic cancer
(locally advanced, unresectable or metastatic)Ø Approved for 1st line in combination with
gemcitabine in the US and EUl Conducting studies for further label expansion
*
*Referred from the disclosure of OSI
11
450383
122
107
94100
559495
73
67
Growth of Local Products in Each Region, Other than Global Products
131.3150.0
232.3224.4
51.428.7
(Billion yen) ($ million)
Europe
Others+17%
Eligard+14%
Scan+13%
AmBisome+9%
Americas
FY2010FY2009 FY2009 FY2010
Newproducts
+79%
SymbicortCelecoxGeninaxIrribowBonoteo
Mainstayproducts
+4%
Japan
LipitorMicardis
familyMysleeSeroquel
FY2009 FY2010FY2009 FY2010
Total(Billion yen)
403.2415.1
491
573
663
727
529.3542.2
Royalty of bendamustin
andLegacy products
etc.
(€ million)
12
Japan: Sales of Major Products
FY10Revenue(bln. yen)
Changes vs PY
(%)
Progress per FY10 Forecasts
(%)
[Total Sales in Japanese Market] 525.6 +3.1 102
Prograf/ Graceptor 39.6 +17.3 102Vesicare 25.5 +11.2 98Gaster 41.7 -16.5 102Harnal 29.6 -15.3 100Lipitor 97.2 -2.7 101
Micardis/Micombi/Micamlo 75.8 +5.9 105Myslee 32.7 +12.1 102
Seroquel 26.4 +12.0 102Celecox 25.1 +41.2 97Geninax 10.2 +25.5 109
Symbicort 11.9 +689.0 117Bonoteo 2.4 +123.9 111Irribow 1.6 +673.8 105
Vaccines 18.7 -26.0 95
Japan
Progress per FY10 forecasts for total sales in Japanese
market: 102%
Growth of new products:51.4 billion yen in total(+78.9% vs PY)
Solid trend in mainstay products (Lipitor, Micardisfamily, Myslee and Seroquel)
Increases Despite Impact from NHI Drug Price Revision
Prograf in good shape
12
13
FY10Revenue($ million)
Changesvs PY
(%)
Progress per FY10 Forecasts
(%)
[Total (incl. OSI)] 2,176 +12.4 97[Total (excl. OSI)] 1,805 -6.8 -
Tarceva 285 - -DPP4 Royalty 80 - -
Prograf 478 -34.9 103VESIcare 418 +10.5 93
Scan(Adenoscan + Lexiscan) 559 +12.8 99
Mycamine 98 +20.2 105Protopic 83 +5.6 87
AmBisome 73 +8.8 108VIBATIV
(launched in Nov. 2009) 9 +126.4 -
Progress per FY10 forecasts for total sales of Americas:
97%
Growing products (Scan, Mycamine) in good shape
Solid Overall Business Compared to FY09 Due to Growth of Growing Products (excl. Prograf), Just Behind FY10 Forecasts
AmericasAmericas: Sales of Major Products
Revenues of OSI $371 million
13
14
FY10Revenue (€ million)
Changesvs PY
(%)
Progress per FY10 Forecasts
(%)
[Total] 1,678 -6.7 103PrografAdvagraf
592122
+8.4+32.3
106
Vesicare 208 +18.9 98Harnal
Sales by AstellasBulk and Royalties
23719046
-55.5+2.7
-86.6
107103125
Eligard 122 +13.9 102Protopic 46 +9.3 100
Mycamine 21 +126.4 93Qutenza 1 - -
Progress per FY10 forecasts for total sales of Europe: 103%
Favorable Overall Business Due to Growth of Mainstay Products excl. Bulk and Royalties of Harnal
Europe
Eligard in good shape
Harnal sold by Astellas in solid trend
Prograf continuously in solid trend
Europe: Sales of Major Products
Sales through Astellas’s own channel*: €1,575 million (+12.1%)
*Excluding bulk and royalties of Harnaland exports to third parties of Prograf
14
15
FY10Revenue (bln. yen)
Changes vs PY
(%)
Progress per FY10 Forecasts
(%)
[Total] 33.7 +12.5 100
Prograf 14.8 +15.6 106
Harnal 9.2 +7.6 100
Vesicare 1.4 +32.4 97
Mycamine 1.6 +56.9 90
Protopic 0.9 +31.2 73
Progress per FY10 forecasts for total sales of Asia: 100%
Solid Trend Due to Growth of Prograf and New Products
Asia
Prograf continuously in good shape
Asia: Sales of Major Products
High growth of new products (Vesicare, Mycamine) compared to PY
15
Excl. FX impact: +17.6% vs PY
16
Outcome in FY2010-Expanded Global Marketing Network
Europe
Americas
Asia
Sales through own affiliates in more than 40 countries
Japan -Strengthened sales and marketing base by mainstay and new products-Launched Micamlo in October 2010-Reinforced vaccine business
Initiated co-promotion with KAKETSUKEN in Kyushu area (October 2010)Agreement for Japanese encephalitis vaccine (January 2011)
-Strengthened oncology capabilities by integration of OSI (June 2010)
-Strengthened business base in South East Europe (December 2010)Established a new affiliate in Slovenia, for regional management of Astellas’ South East European business
-Strengthened business in China-Launched many products throughout Asia
Vietnam/Vesicare, Harnal (August 2010), China/Advagraf (March 2011), Korea/Irribow (September 2010), India/Advagraf (April 2011), Thailand/Prograf (additional indication for lupus nephritis) (November 2010)
-Established sales affiliate in Australia for further expansion of business areas (December 2010)
16
17
Business Expansion in Emerging Countries-Expecting Continuous High Growth
Russia
China
- High growth rate: +32% (FY2010, EUR)- The 3rd largest sales among European countries- Further expansion in CIS
-Potential market with promising high growth rate-Launched Omnic, Protopic and Mycamine
Brazil
- High growth rate: +22% (FY2010, local currency)- Sales in FY2014: Aim for more than double of FY2010- Increase MRs to expand customer coverage
FY2010FY2009
China
Russia
China
Russia
Brazil
Approx. 30.0 billion yen
FY2011Forecast
India
India-Potential market with promising high growth rate-Launched Prograf/Advagraf, co-promotion of Micamine
Established the affiliate in 1994Long track record, strengthen the business base further
Established the affiliate in 1994Strengthen the business base further
Established the affiliate in 2009Aim to build business base early by launch of in-house products
Established the affiliate in 2008Aim to build business base early by launch of in-house products
18
Outcome in FY2010- Alliance Activities
Q1/FY2010 Q2/FY2010 Q3/FY2010 Q4/FY2010
July 2010Regeneron’sVelocImmune
technology Extension of
license agreement
September 2010UMN-0501/0502Influenza vaccines
October 2010AKP-002
Lower urinary tract symptoms associated
with BPH
October 2010Diannexin
Prevention of DGF in kidney transplantation
February 2011fidaxomicin
Clostridium difficileinfection
February 2011tivozanib
Renal cell carcinoma etc.
January 2011ENCEVAC
Japanese encephalitis vaccine
JapanApril 2011 Launch
Phase 3
Phase 1
Phase 2
December 2010Strategic equity
agreement with Cytori
Phase 2
Filed
March 2011Perseid
Exercised buy-out option
June 2010OSI acquisition
Integrating activitiesJune 2011Plan to complete integration
January 2011Started to review strategic business alternatives for Prosidion subsidary
June 2010Kyushu area
Distribution and co-promotion of vaccines
Japan
BPH: Benign Prostatic Hyperplasia, DGF: Delayed Graft Function
19
Forecasts for FY2011
19
FY2010Results
FY2011Forecasts
Change
Net sales 953.9 974.0 +2.1%R&D
R&D ratio217.322.8%
199.020.4% -8.4%
Operating income (OP) 119.1 135.0 +13.3%
*OP before amortization of OSI and Agensys
146.6 167.8 +14.5%
Ordinary income 115.0 136.5 +18.6%
Net income 67.6 81.0 +19.7%
(Billion yen)
lExchange rate (average)USD 86 yen 80 yen -6 yenEUR 113 yen 110 yen -3 yen
Impact of the Eastern Japan Earthquake on earnings
ØImpact on net sales:Approx. Δ5.0 billion yen
-Reaction to tentative increase of channel inventory due to the earthquake in FY2010
ØImpact on operating income:Approx. Δ2.0 billion yen
-Decrease in gross profit due to sales decrease
-Transfer of the fixed costs arising from the suspension of operations of laboratories and factories to the special losses
ØSpecial losses:Approx. 1.5 billion yen
-Fixed costs arising from the suspension of operations of laboratories and factories
20
Forecasts for FY2011: Factors of Fluctuation in Sales
Increasep Global/ Vesicare, Mycaminep Japan/ Symbicort, Celecox,
Micardis family etc.Decreasep US and Europe/Prografp Japan/ Harnal, Gaster, Lipitor
9,840
FY2010Results
FY2011Forecasts
Factors of fluctuation in sales(Billion yen)
953.9
974.0
+20.0
Increase of sales at OSI: +10.3 billion yen
Increase of sales from ordinary business: +19.7 billion yen
FX impact: Δ19.6 billion yen
Impact of the earthquake:Approx. Δ10.0 billion yen
FY2010 results: 31.8 billion yen (9 months)FY2011 forecasts: 42.1 billion yen (12 months)
21
Forecasts for FY2011: Factors of Fluctuation in Operating Income
21
Increasep Increase of gross profit due to
increase of net salespDecrease of R&D expenses
119.1135.0
FY2010Results
FY2011Forecasts
Factors of fluctuation in operating income(Billion yen)
Impact of OSI amortization: Δ5.7 bln. yen+15.8
pOSI amortization: 5.7 bln. yen increase
Impact of the earthquake: Approx. Δ 5.5 bln. yen
Increase from ordinary business: +27.0 bln. yen
FX impact: Δ2.9 bln. yen
Operating income before OSI amortization: 160.9 bln. yen
FY2010 results: 20.1 bln. yenFY2011 forecasts: 25.9 bln. yen
22
Sales Forecasts by Geographical Area
2,408
2,176
FY11
FY10
1,739
1,678
FY11
FY10
39.2
33.7
FY11
FY10
日本
Asia
Europe
Americas
(億円)
(Billion yen)($ million)
550.8
543.8
FY11
FY10
Japan
FactorsPrograf/Advagraf
Harnal (Sales by Astellas)Harnal bulk and royalties
VesicareMicamineEligard
Factors
FactorsMycamaineVesicareHarnal
Protopic +0.9Prograf +0.6FX impact -0.6
Factors
(+3.6%)
(+10.7%) (+16.2%)
(+1.3%)
OSI-related revenuesVesicareScan
+156+73+12
+8-48
+1.4+1.0+1.1
-37 (Incl. Export)-12-11
+38+9+6
GasterLipitorHarnal
-4.9-4.5-2.5
Symbicort +12.3Celecox +5.7Micardis family +5.5Prograf +4.8
(Forecasts)
(Forecasts)
(Billion yen)
($ million) (Billion yen)
(Forecasts)
(Forecasts)
MycaminePrograf
(€ million)
(€ million)
Increases in all the area, Japan/Europe/Americas/Asia
*Sales in the Japanese market FY10: 525.6à FY11 Forecasts: 533.0 (+1.4%)
(Billion yen)
*Sales through Astellas’ own channel: 1,658 (+5.3%)
23
Global Sales Forecasts for FY2011
12.6 12.4
8.4 8.5
2.4 3.4 1.6
3.0
FY2010 FY2011 Forecasts
25.5 27.2
35.839.3
23.527.1
FY2010 FY2011 Forecasts
Asia
Europe
Americas
Japan
(Billion yen)86.7
96.3 (+11.2% vs PY)
27.4 (+9.3% vs PY)25.1
Aisa
Europe
Americas
Japan
Vesicare
p Japan: +7%p Americas: +18% (USD)p Europe: +18% (EUR)p Asia: +80% (Excl. FX impact)
1.4
2.5
p Japan: -2%p Americas: +9% (USD)p Europe: +47% (EUR)p Asia: +93% (Excl. FX impact)
(Billion yen)Funguard/Mycamine
Growth of Vesicare and Funguard/Mycamine
24
Global Sales Forecasts for FY2011
29.6 27.1
21.519.6
9.210.3
5.23.8
FY2010 FY2011 Forecasts
39.6 44.5
41.0 34.3
60.6 56.0
14.815.5
6.55.1
FY2010 FY2011 Forecasts
Asia
Europe
Americas
Japan
162.6155.5 (-4.4% vs PY)
Export
66.5
Asia
Europe
Japan
Bulk and Royalties
p Japan: +12%p Americas: -10% (USD)p Europe: -5% (EUR)p Asia: +7% (Excl. FX impact)
61.7 (-7.3% vs PY)
p Japan: -9%p Europe: -7% (EUR)p Asia: +13% (Excl. FX impact)p Bulk and Royalties: -25% (EUR)
(Billion yen) (Billion yen)
Slow down of decreases in Prograf and Harnal sales
HarnalPrograf
25
107.9131.3
236.2232.3
74.351.4
515450
129
122
12594
571559
7073
527
371
Local Sales Forecasts for FY2011, Excluding Global Products
(Billion yen) (€ million) ($ million)Europe
Others+15%
Eligard+5%
Scan+2%
OSI-related
revenues+42%
Americas
FY2011FY2010 FY2010 FY2011
New products
+44%
SymbicortCelecoxGeninaxIrribowBonoteo
Mainstay products
+2%
Japan
LipitorMicardis
familyMysleeSeroquel
FY2010 FY2011FY2010 FY2011
Total (Billion yen)Portfolio accumulation builds up net sales growth
415.1 418.4
5731,098
644
1,294
574.0592.8
AmBisome-4%
Forecasts Forecasts Forecasts Forecasts
+ €65M
+ $156M
+22.8bln. yen
+3.8bln. yen
Royalty of bendamustinand legacy
products etc.
Global Pipeline
27
:In-house, additional indication or additional formulation Red: Changes from the previous announcement
Status of Astellas’ Pipeline
Filed P3 P2 P1
Urology ASP7035ASP0306ASP4901 (AKP-002)
TransplantationImmunologyInfectious
diseases
ASP015K (JP)ASKP1240 (JP)ASP2408ASP3291, ASP4058telavancin (JP)
Oncology MDV3100 (JP)YM155 (JP)AGS-16M8FASG-5ME, ASP1707ASP3026, ASP9521AGS-22M6E,tivozanib(Breast etc.)
Neuroscience ASP0777, FK949E ASP8477
DM Complications & Metabolic diseases
ASP4178ASP5034
Others ASP1517 (JP)YM311 (JP) ASP0456ASP7147
ASP8825(Restless legs syndrome, JP)
YM150 (VTE, JP/Asia)YM529 (1M, JP)YM443 (FD, JP)
telavancin (NP, US)
RSD1235 (AF, US)
ASP3550 (1M, JP)
telavancin (cSSTI/NP, EU)
mirabegron (OAB, JP)
YM177 (Acute pain, JP)
ASP1585 (Hyperphosphatemia, JP)
mirabegron (OAB, EU/US)solifenacin/tamusulosin (EU)
ASP1941 (DM, JP)
YM533 (Chronic renal failure, JP/Asia)
isavuconazole (Aspergillosis, candidemia, EU/US)
MDV3100 (EU/US)elrotinib (US)OSI-906(Adrenocortical, US)
ASP015K (Transplant, US)
YM150 (VTE:EU/US, AF:EU/JP/Asia, ACS:EU)ASP1517 (EU)
ASP1941 (DM, EU/US)
ASKP1240 (Transplant, US)
YM060 (Female, JP)
AC220 (EU/US)
ASP3550 (3M, JP)
OSI-906 (Ovarian etc, US)
YM905 (Pediatric, EU/US)
diannexin (Transplant, US)
PSN821 (DM, Obesity, EU)
OSI-027 (US)
YM060 (OD, JP)
YM155 (EU/US)
AGS-1C4D4 (EU/US)
:In-house new molecular entity :Licensed-in
OAB: Overactive Bladder, cSSTI: Complicated Skin and Soft Tissue Infections, NP: Nosocominal Pneumonia, CDI: Clostridium difficile infection, FD: Functional Dyspepsia, VTE: Venous Thromboembolism, AF: Atrial fibrillation, ACS: Acute Coronary Syndrome, OD: Orally-disintegrating
fidaxomicin (CDI, EU)
solifenacin/mirabegron (EU)
tivozanib (RCC, EU/US)
ASP7373 (Influenza, JP)ASP7374 (Influenza, JP)
ASP3652 (EU)
YM311 (EU)
28
Change in Pipeline Status since February<Filed Projects>
Project Therapeutic Target Area Stage Remarks
ASP1585(AMG223)bixalomer
Hyperphosphatemia in patients with chronic kidney disease
on dialysis Japan Filed NDA was filed in Japan
(March 2011)
YM177celecoxib
Anti-inflammatory and analgesic effects in post-
operation, post-trauma, and post-tooth extraction
Japan Filed sNDA was filed in Japan (March 2011)
fidaxomicin Clostridium difficile infection Europe Filed In-licensed from Optimer in February 2011 (New)
29
Change in Pipeline Status since February<New, Stage Up>
Project Therapeutic Target Area Stage Remarks
tivozanibRenal cell carcinoma US/
EuropeP3 In-licensed from AVEO in
February 2011 (New)Breast cancer, colorectal cancer P1/2EB178
solifenacin/mirabegron
Urinary frequency, urinary incontinence or urgency
associated with overactive bladder
Europe P2 Entry into P2 in Europe (New)
ASP7373(UMN-0501) Prophylaxis of H5N1 influenza Japan P2b Entry into P2b in Japan (New)
(In-licensed from UMN Pharma)ASP7374
(UMN-0502)Prophylaxis of seasonal
influenza Japan P1/2 Entry into P1/2 in Japan (New) (In-licensed from UMN Pharma)
ASP3652 Chronic prostatitis/Chronic pelvic pain syndrome Europe P2 Entry into P2 in Europe
ASP1517(FG-4592) Renal anemia
Europe P2 *Licensed territory: EU, Japan etc.FibroGen initiated P2b for patients on dialysis in US (Another P2b is ongoing for patients not on dialysis)Japan P1
YM150darexaban
Prevention of venous thromboembolism (VTE) after
major orthopedic surgery
Japan/Asia P3 Withdrew NDA filing in Japan
in February 2011
nNDA filing withdrawn
30
Change in Pipeline Status since February< Development Discontinuation, New P1>
Project Therapeutic Target Stage Remarks
ASP9521 Prostate cancer P1 New entry into P1
AGS-22M6E Cancer (ADC) P1 New entry into P1
ASP7147 Irritable bowel syndrome P1 New entry into P1
Project Therapeutic Target Area Stage Remarks
ASP2151 Herpes zoster, Genital herpes
JapanUS
P2(Development suspended)
We have decided to discontinue the development of ASP2151 as a result of the investigation of serious adverse events observed in a 28-day safety study in healthy subjects.
nDevelopment discontinuation
nNew P1
31
Mirabegron (YM178): Development Progress
31
n P3 long-term safety study: Study completedn Additional thorough-QT (TQT) study: Summary results obtainedn A clinical study to investigate the intraocular pressure:
Last patient out achieved, data under review
US and EU: Schedule NDA filing in 2Q/FY2011
Japan: NDA filing in June 2010
Asia: Multinational P3 is ongoing (China/Korea/Taiwan/India)
The results of P3 in the EU/US were presented at EAU* on March 21, 2011.
EAU: European Association of Urology
32
Mirabegron (YM178): Summary Results of Additional TQT Study
Study outlinel Study design: Randomized, double-blind, crossover assignmentl Treatment period: 10 daysl Treatment arms: mirabegron, moxifloxacin, placebol Number of subjects: 352 subjects l Primary endpoint: QTcI evaluated through electrocardiogram analysis
▼
Summary ResultsQTcI at the therapeutic dose was below the threshold for regulatory concern.
▼
The results will be scientifically presented in 2011 or 2012.
33
Efficacy results
Mirabegron 50 and 100 mg once daily over 12 weeks demonstrated superior efficacy compared with placebo against the key OAB symptoms of urinary incontinence and micturition frequency.
*Excerpt from the poster presented at EAU on March 21st by Dr V Khullar(St Mary’s Hospital, Imperial College, Urogynaecology Department)
Mirabegron (YM178): Results of P3 in EU Presented at EAU
34
Ipragliflozin (ASP1941): Development Progress
Recent update of development statusnJapan: Monotherapy P3 study (DBT): Study completed, data under analysis
Five add-on P3 studies: Recruitment completed nUS/EU: Monotherapy P2b study in US and add-on P2b study with metformin
in Europe and US: Last patient out achieved
▼
Last patient out (n=380, 12w)
Last patient out (n=320, 12w)
Recruitment completed (n=150, 52w)
Study completed, data under analysis (n=120, 16w)
JP
EU/US
US
Dose finding add-on study with metformin P2b
Monotherapy dose-finding P2b
Recruitment completed (52w) Metformin (n=150), SU* (n=225), Pio *(n=150), a-GI* (n=100), DPP4 *(n=100)
Ongoing Nate* (n=100, 52w)
P3P1 P2
Monotherapy(placebo controlled DBT)Monotherapy(long term safety)Add-on studies with other anti-hyperglycemic drugs
*SU: Sulfonylureas, Pio: Pioglitazone, a-GI: a-Glucosidase inhibitor, DPP4: DPP4 inhibitor, Nate: Nateglinide
Long-term renal impairment Ongoing (n=150, 52w)
35
Darexaban (YM150): Development Progress
Recent update of clinical trial statusnP2b/3 for VTE in EU/US, P2b for AF* in EU/JP/Asia: CompletednP2b for ACS* in Europe: Last patient out achieved
*VTE: Venous Thromboembolism, AF: Atrial Fibrillation, ACS: Acute Coronary Syndrome, TKR: Total Knee Replacement, THR: Total Hip Replacement
VTEprevention
AF
ACS
P3P1 P2
Europe/Japan/Asia
Japan/Asia
US
Europe/US
Europe
Completed
NDA filling withdrawn
Completed
Completed
Expected completionin 1st half 2011
P2b study in TKR*: n=681 (darexaban: QD/BID, warfarin)
1) TKR n=366, 2) THR n=609,(darexaban: BID, placebo, enoxaparin)
3) Hip fracture surgery, 4) Abdominal surgery, 5) Acute medical illness, 6) History of VTE
P3 studies in Japan/Asia
P2b/3 study in THR*: n=1,922(darexaban: QD/BID, enoxaparin)
P2b study in AF: n=1,297 (darexaban: QD/BID, warfarin)
P2b study in ACS: n=1,264 (darexaban: QD/BID, placebo ontop of standard therapy)
ØOver 9,000 subjects enrolled in the darexaban clinical program
Aims for an anticoagulant with the best risk-benefit balance
36
Oncology Pipeline ExpansionProject
Product Name Target cancer Characteristics P1 P2 P3 Filing
Small m
olecule
MDV3100 Prostate cancer Second generation AR * antagonist EU/US/JP
tivozanib Renal cell carcinoma, breast cancer, colorectal cancer
Triple VEGFR tyrosine kinaseinhibitor
Renal: EU/US
AC220 Acute myeloid leukemiaPotent and highly selectivesecond generation FLT3kinase inhibitor
EU/US
ASP3550degarelix Prostate cancer First GnRH* antagonist in
Japan1M formulation: JP
3M: JP
YM155 Breast cancer, Non-Hodgikin’s lymphoma
A “First-in-class” survivinsuppressant EU/US/JP
ASP1707 Prostate cancer, EndometriosisASP3026 Cancer ALK tyrosine kinase inhibitorASP9521 Prostate cancer
OSI
Tarceva(Extension)
NSCLC (1st line for patients with EGFR mutation, adjuvant),Hepatocellular carcinoma
HER1/EGFR tyrosine kinaseinhibitor US
OSI-906Adrenocortical carcinoma, Ovarian cancer, NSCLC, Hepatocellular carcinoma
IGF-1R/IR tyrosine kinaseinhibitor
Adrenocortical: US
Ovarian etc: USOSI-027 Renal cell cancer mTOR kinase inhibitor US
Antibody
AGS-1C4D4 Pancreatic cancer Novel antibody target (prostate stem cell antigen) EU/US
AGS-16M8F Renal cancer Antibody utilizing ADC
ASG-5ME Prostate cancer, Pancreatic cancer Antibody utilizing ADC
AGS-22M6E Solid tumors Antibody utilizing ADC*AR: Androgen Receptor, GnRH: Gonadotropin Releasing Hormone
Added
New
New
37
Tivozanib
nMechanism of Action: Block the VEGF pathway by inhibiting all three VEGF receptors
nPotential Indication:Renal cell carcinoma (RCC)Breast cancer, Colorectal cancer
nDevelopment Status RCC (monotherapy): P3 (global)Breast cancer, colorectal cancer: P1/2 *P3 [TIVO-1 study]: RCC/monotherapy
-Pivotal global P3 comparing the efficacy and safety of tivozanib with sorafenib(Nexavar), n=500-Target: Patients with advanced RCC-Completed enrollment in August 2010.
Takahashi H et al. Clin. Sci. (2005) 109, 227-241
tivozanib
Partnership with AVEO in February, 2011
38
Fidaxomicin
nClassification: Orally administered, macrocyclic antibiotic with a new mechanism and narrow spectrum of action.
nIndication: Clostridium difficile* infection (CDI) * A bacteria that causes inflammation of the colon, severe diarrhoea and in the most serious cases, death
nDevelopment status: Filed NDA application in EU and US** Licensed territory: Europe, Middle East, Africa and CIS
Results of two Phase 3 studies-Showed non-inferiority compared to oral vancomycin in achieving clinical cure-Statistically superior to vancomycin in global cure and in reducing recurrences of CDI by up to 47%
Significant unmet medical need for CDILimited treatment, high recurrence rate, significant health and
economic burden, increasing incidence
Partnership with Optimer in February, 2011
39
FY2010 Development Progress
Phase 3 NDA Filing
VesicareOD
Launched
acotiamideYM443
degarelixASP3550
1M
telavancin(VIBATIV)
telavancin
vernakalantRSD1235
Prodrug ofgabapentin
ASP8825(XP13512)
solifenacin/tamusulosin
mirabegronYM178
celecoxib(Celecox)
YM177
bixalomerASP1585
ipragliflozinASP1941
beraprostsodium(Dorner)YM533
fidaxomicin
tivozanib
Japan Europe US EU/US
mirabegronYM178
minodronateYM529
New entry
MDV3100
isavuconazole
darexabanYM150
elrotinib(Tarceva)
OSI-906
40
Initiatives in FY2011-Specific Approaches for GrowthMaintain and expand the business base in urology and transplantationareas, continuing as the Global Category Leader (GCL)
Build up the business base of oncology early to be the GCL in the 3rd
therapeutic area
Maximize the sales of global products and many local products suitable to characteristics in each area
Reinforce oncology/antibody research (Japan, OSI and Agensys)
Continue in-licensing and alliance activities suitable for therapeutic area strategy and local business basesImprove cost efficiency further
Therapeuticarea
strategy
Regionalstrategy
R&D innovation
strategy
nMaximization of the sales of Vesicare, NDA filing of mirabegron in Europeand the US.nMaintenance of Prograf sales by increasing Advagraf sales, continuous
contribution to medical transplantation
nComplete the integration of OSI and make the most of itnSteadily promote the development of projects in the oncology pipeline
Strengthen the business in emerging countries and expand business areas further
Accelerate translational science
Promote approach to new drug discovery technologies (vaccines, protein, regenerative medicine)
41
850
900
950
1,000
1,050
1,100
1,150
FY2010 FY2011 FY2012 FY2013 FY2014
Overcome Patent Expiry of Main Products and Realize the Continuous Growth
Net sales(Billion yen)
Forecasts Targets*
1096.0
*Targets presented at 2Q/FY10 financial results announcement in November 2010: Including OSI impactForecasted exchange rates: 80 yen/USD, 110 yen/EUR
Operatingincome
226.0 bln. yen
Operatingincome
135.0 bln. yenOperating
income119.1 bln. yen
953.9
974.0
Net sales and operating income grow continuously from the bottom in FY2010
42
Profit Distribution Policy
FY2010 FY2011 Forecasts
EPS 146.49 yen 175.39 yenDividends per
share125 yen
(Plan) 125 yen
ROE 6.5% ―
DOE 5.6%(Plan) ―
Share buyback* ― Implemented in a flexible manner
Top priority on investment for growth in Rx business▼
Dividends to be increased continuously based on the mid and long-term growth
▼
Share buyback to be implemented in a flexible manner▼
42
*Excluding amounts for the buyback of shares consisting less than one unit