0

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