Financial Results Financial Results forfor 1Q/FY 2012 Ending1Q/FY 2012 Ending March 31March 31 20132013for for 1Q/FY 2012 Ending 1Q/FY 2012 Ending March 31, March 31, 20132013

August 1, 2012Yasumasa MasudaSenior Corporate Executive,Chief Financial OfficerA t ll Ph IAstellas Pharma Inc.

0

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 factorsActual 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 marketpricing 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 liti tilitigation.

This material contains information on pharmaceuticals (including compounds under development) but this information is not intended to make any representations ordevelopment), 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.

1

1Q/FY2012 Financial Results

1Q/FY11 Actual

1Q/FY12 Actual

Change 2Q/FY12 Forecasts

Progress per 2Q/FY12

(Billion YEN)

Actual Actual ForecastspForecasts

Net Sales 251.6 243.2 -3.3% 476.0 51.1%COGs

as % of sales77.430 8%

73.430 2%

--0 6ppt Total amortizationas % of sales 30.8% 30.2% 0.6ppt

SG&A Excluding R&D

as % of sales

81.732.5%

74.030.4%

-9.5%

R&D Expenses 43 5 42 8

Total amortization for OSI and Agensys

•1Q/FY11 8.1 bn YEN (of which OSI: 6.3)•1Q/FY12 6.0 bn YEN

R&D Expensesas % of sales

43.517.3%

42.817.6%

-1.5% 86.0 49.8%

Operating Incomeas % of sales

48.819.4%

52.821.7%

+8.4% 75.0 70.5%

(of which OSI: 4.3)

Ordinary Income 50.3 55.7 +10.7% 75.5 73.8%

Net Income 25.1 35.4 +41.1% 52.0 68.2%

-Special gain and loss (net)-8.1 bn YEN

-Decrease in income tax b d t (47 0% 25 6%)

●Exchange Rates (Average for the FY; YEN)

Comprehensive Income 14.3 -4.0 -128.5%

burden rate (47.0% → 25.6%)

2

USD 82 80 2 strengthening of YEN

80

EUR 117 103 14 strengthening of YEN

105

1Q/FY2012 Results: Analysis of Change in Sales

Major positive factors

(Billion YEN)

-8 3

[Sales vs. Previous FY] -8.3 (Billion YEN)

Major positive factors Global/Vesicare +0.7

Funguard/Mycamine +0.9 Japan/Micardis [Family] +1 1

-8.3

Japan/Micardis [Family] +1.1Growth of New Product Group +6.5Celecox, Symbicort, Geninax, Bonoteo,Argamate, Betanis251.6 243.2 g

Americas/Scan +0.7Tarceva +1.0

251.6 243.2

Major negative factors Grobal/Prograf -2.0

Harnal -3.4 Japan/Lipitor [Family] -5.8

1Q/FY2011 1Q/FY2012

Gaster -1.8 Americas/ Absence of DPP-IV royalty of the

previous year (due to sale of DPP-IV related assets) 2 2

3

[Forex impact: -8.1][Impact of NHI drug price reduction in Japan: -6.2]

assets) -2.2

1Q/FY2012 Results:Analysis of Change in Operating Income (OP)Analysis of Change in Operating Income (OP)

Decrease in gross profit: 4 3 <negative factor>(Billion YEN)

+4 0[OP vs. Previous FY] +4.0

(Billion YEN)

Decrease in gross profit: -4.3 <negative factor>

Decrease in sales: -8.3

Decrease in COGs ratio: -0.6ppt

Decreasing factor:

+4.0

-Decreasing factor: Forex impact on elimination of unrealized gain

-Increasing factor: Change in product mix, including impact of change in lipitor contract48.8

52.8including impact of change in lipitor contract8 8

Decrease in R&D expenses: -0.6 <positive factor>

Impact from the change in depreciation method:Approx -1 2

Decrease in SG&A excluding R&D expenses: -7.7

<positive factor>

Decrease in cost for VESIcare b siness in

Approx. -1.2

1Q/FY2011 1Q/FY2012

Decrease in cost for VESIcare business in the US

Decrease in amortization cost due to sale of the DPP-IV related assets in the previous year

4

[Forex impact: -0.1]

the DPP IV related assets in the previous year

Sales by Region (local currency basis)

Increases in Europe/Asia, Decreases in Japan/Americas

*Calculated based on the location of the seller

Japan Europe

1Q/FY12Y Y

Progress per 1Q/FY12Y Y

Progress per1Q/FY12revenue

(Billion YEN)

YoY(%)

Progress per 2Q/FY12

Forecasts (%)

137.7137.7 --1.21.2 49.649.6

1Q/FY12 revenue

(Million EUR)

YoY(%)

Progress per 2Q/FY12

Forecasts (%)

477477 +2.0+2.0 54.754.7

-Growth in Vesicare, Mycamine and Eligard-Continuous contribution of bendamustin revenues

and legacy products: 145 million EUR (+11%)

Sales in Japanese market: 134.0 bn YEN (-0.4%)-Impact of NHI drug price reduction and generic products-Contribution of major growing products and new products

Americas Asia

1Q/FY12revenue

YoYProgress per

2Q/FY121Q/FY12

YoYProgress per

2Q/FY12revenue(Million USD)

(%)2Q/FY12

Forecasts (%)

579579 --1.81.8 52.852.8

revenue(Billion YEN)

YoY(%)

2Q/FY12Forecasts (%)

9.99.9 +9.6+9.6+13.1+13.1

excluding 52.552.5

5

-Growth in VESIcare, Scan and Tarceva-Absence of DPP-IV royalty of the previous year: $-27M -Growth driven mainly by Prograf

forex impact

Urology: Vesicare, Betanis and Harnal

Three Urology Products

Growth of Vesicare

Vesicare

0.70.5

(Billion YEN)

43.141 1 (-4 6%YoY)

26.7 (+3.1%YoY)25.9(Billion YEN)

Three Urology ProductsVesicare

7.2 7.6

17.2 13.8

Asia

Europe

Americas

41.1 ( 4.6%YoY)

Harnal

9.9 10.60.6

Japan BetanisJapan: Launched in Sep. 2011Top Share

in Japan US7.9 7.8

1Q/FY2011 1Q/FY2012

25.9 26.7

Vesicare

in Japan, US and Europe

US (Myrbetriq) Approved in Jun. 2012

1Q/FY2011 1Q/FY2012

Japan: -1% Americas: +8% (USD basis ) Europe: +19% (EUR basis)

Vesicare

[YoY]

6

1Q/FY2011 1Q/FY2012 Europe: +19% (EUR basis) Asia: -11% (excluding forex impact)

Immunology (Including Transplantation) and Infectious Diseases:

Prograf and Funguard/MycaminePrograf and Funguard/Mycamine

Prograf

Softening of decreasing trend in Prograf, Growth in Funguard/Mycamine

Funguard/Mycamine

0.51.7 1 1 Asia

(Billion YEN)

41.7 39.7 (-4.8%YoY)7.3 (+14.8%YoY)

6.3

(Billion YEN)

Prograf Funguard/Mycamine

2 0 2.2

0.81.20.4

17.2 14.1

3.7 4.4 1.1

Europe

Americas

Japan

Asia

Europe

Exports

3 2

2.0

7.9 7.5

pAmericas

Japan

[US]Generics’ share of TRx:

3.1 3.2

11.0 12.4

66% (Week of Jul. 20, 2012)Apr. to Jul. cumulative: 65%

1Q/FY2011 1Q/FY2012 1Q/FY20121Q/FY2011

Japan: +12% Americas: -3% (USD basis) Europe: 6% (EUR basis)

Japan: +6% Americas: +15% (USD basis) Europe: +72% (EUR basis)

[YoY] [YoY]

7

Europe: -6% (EUR basis) Asia: +22% (excluding forex impact)

Europe: +72% (EUR basis) Asia: +23% (excluding forex impact)

Oncology: Tarceva and Eligard

Combined Tarceva and Eligard revenues grew to 12.8 billion YEN

Tarceva-related Revenues Eligard (Europe)(Million USD)

( % )

(Million EUR)

43

114 (+15.7%YoY)

98 31

35 (+12.3%YoY)

42

43

71

Non-US revenue

US revenue56

US revenue

8

1Q/FY20121Q/FY2011 1Q/FY2011 1Q/FY2012

Major Products in Japan (excluding global products)

Growth of major products and new product group

(Billion YEN)

New Product Group

22 622.0

Micardis [family](Micardis, Micombi, Micamlo)

(+5 3%YoY)(+36.7% YoY)

Lipitor [family](Lipitor, Caduet)

21.522.6

16 1 Symbicort

(+5.3%YoY)

6.0

1.5 Argamate24.7

18 9( 23 5%YoY) 16.1 y(+31.6%)

Bonoteo(+208.2%)

2.24.5

18.9(-23.5%YoY)

( 208.2%)

Geninax(+2.3%)

2.92.9

0.7

Celecox(+17.4%)

9.27.9

9

1Q/FY20121Q/FY2011 1Q/FY2011 1Q/FY20121Q/FY20121Q/FY2011

Launch in Japan:Kiklin Capsules and Regnite Tablets in Europe: DIFICLIR Tabletsin Europe: DIFICLIR Tablets

Kiklin Capsules (Launch: June 2012 in Japan)Indication: Treatment of hyperphosphatemia in

ti t di l i ith h i kid di

Regnite Tablets (Launch: July 2012 in Japan)Indication: Treatment of moderate-to-severe primary restless legs syndromepatients on dialysis with chronic kidney disease primary restless legs syndrome

DIFICLIR Tablets (Launch: May 2012 in Europe)( y p )Indication: Treatment of adults with Clostridium difficile infections

10

Continuous Introduction of New Products andOptimizing Resource Allocation

JP/US/EU

Optimizing Resource Allocation■ Continuous product introductions (approvals and launches)

Gonax approval(Prostate cancer)

Myrbetriq approval(Overactive bladder)

Kiklin launch(Hyperphosphatemia )

Symbicort new dosage and administration

(Adult bronchial asthma, as-needed i ddi i i h )

JP/US/EU

DIFICLIR launch(Clostridium difficile

infections)

May EU Jun. JP Jun. JP Jun. US Jun. JP

Regnite launch(Restless legs syndrome)

(use in addition to maintenance therapy)

Combined vaccine approvalQuattrovac subcutaneous

injection syringe

infections)

Jul. JP Jul. JP

Asia and Oceania

TaiwanFebric (febuxostat) launch (May)

SingaporeAdvagraf approval (Apr.)

J 2012 P t hi ith D i t d l ASP7147

( ) ( y)g pp ( p )

■ Optimizing Resource Allocation

Jul. 2012: “Horizon Tablets, Powder, Injection” “Sosegon Tablets, Injection”

Jun. 2012: Partnership with Drais to develop ASP7147Transferred the assets to Seldar - “Multi-Track R&D” Approach -

11

Decided to transfer marketing and manufacturing authorization rights to Maruishi (Effective from Oct. 2012)

Overcoming Patent Expiry of Major Products and Posting Sustained Growth

Continuous growth in net sales and OPfrom the bottom in FY2010

Continuous growth in sales and OP since the FY2010 low

Posting Sustained Growth

1,150

Net sales(Billion YEN) OP

226.0bn YEN

from the bottom in FY2010

DOE 6%ROE 15%

OP

1,050

1,100

1 096 0

OP131.5bn YEN

OP146.0bn YEN

950

1,000

1,096.0OP119.1bn YEN

900

950

953.9

969.3972.0

850 FY2010 FY2011 FY2012 FY2013 FY2014

Forecasts Targets

N h i FY2012 f t

12

No change in FY2012 forecasts announced in May 2012

R&D PipelineR&D PipelineR&D PipelineR&D Pipeline

Status of Astellas’ Pipeline

Filed P3 P2 P1ASP7035 ASP0306

:In-house, additional indication or additional formulation Red: Changes from the previous announcement:In-house, new molecular entity :Licensed-in

UrologyASP7035, ASP0306ASP4901 (AKP-002)ASP3652 (JP) , ASP6432

Immunology (including ASKP1240 (JP)

mirabegron (OAB, EU)solifenacin/tamsulosin (EU)

ASP015K (RA etc EU/US/JP)

ASKP1240 (Transplant, US)

solifenacin (Pediatric, EU/US)

diannexin (DGF, US)

solifenacin/mirabegron (EU)ASP3652 (CP/CPPS etc., EU)

t li b l

certolizumab pegol(MTX-naive RA, JP)

(including Transplantation)and Infectious Diseases

ASP2408ASP2409ASP4058

sepantronium (JP)

isavuconazole (Aspergillosis, candidemia, EU/US)

enzalutamide (PC, Pre-Chemo

ASP015K (RA etc., EU/US/JP)

linsitinib (NSCLC etc., US)sepantronium

ASP7373 (Influenza, JP)ASP7374 (Influenza, JP)ASP0113 (SOT, EU/US)ASP0113 (CMV reactivation

in HSCT, EU/US)

certolizumab pegol(RA insufficiently responding to current therapies, JP)

enzalutamide (PC, Post-

Oncology

sepantronium (JP)AGS-16M8F/AGS-16C3F

ASG-5ME, ASG-22MEASP1707(PC, EU)ASP3026, ASP9521ASP9603

(etc., EU/US/JP/Asia)erlotinib (NSCLC etc., US) quizartinib (AML, EU/US)

degarelix (3M JP)OSI-027 (RCC, US)

sepantronium(BC etc., EU/US)

AGS-1C4D4 (Pancreatic cancer, EU/US)

tivozanib (RCC, EU/US)

(Chemo EU/US)

enzalutamide (BC)

NeuroscienceASP0777, ASP8477ASP9226, ASP6973

DMipragliflozin (Diabetes, JP)beraprost (Chronic renal

ipragliflozin (Diabetes, EU/US)

degarelix (3M, JP)

PSN821 (Diabetes Obesity EU)

quetiapine (BPD, JP) quetiapine (MDD, JP)tivozanib (BC, CRC, EU/US)

capsaicin (PDN, EU)

DM Complications and Kidney Diseases,Others

ASP7991ASP1517 (JP)YM311 (JP) acotiamide (FD, JP)

beraprost (Chronic renal failure, JP/Asia) ASP1517 (Renal anemia, EU)

ramosetron (IBS Female JP)

PSN821 (Diabetes, Obesity, EU)

ramosetron (IBS OD, JP)YM311 (Renal anemia, EU)

linaclotide (IBS, JP)ASP1707 (Endometriosis,

bixalomer(Hyperphosphatemia in patients not on dialysis.JP )

14

ramosetron (IBS Female, JP)

OAB: Overactive bladder, CP/CPPS: Chronic prostatitis/Chronic pelvic pain syndrome, MTX: Methotrexate, CMV: Cytomegalovirus, HSCT: Hematopoietic stem cell transplant, SOT: Solid organ transplant, DGF: Delayed graft function, RA: Rheumatoid arthritis, PC: Prostate cancer, NSCLC: Non-small cell lung cancer, RCC: Renal cell carcinoma, BC: Breast cancer, AML: Acute myeloid leukemia, CRC: Colorectal cancer, FD: Functional dyspepsia, OD: Orally-disintegrating, BPD: Bipolar disorders, MDD: Major depressive disorder, IBS: Irritable bowel syndrome, PDN: Peripheral diabetic neuropathy

(EU/JP)

Changes in Pipeline Status Since May 2012 <Approved and Filed><Approved and Filed>

Product Name Target Disease Area Stage Changes

Approved

(Generic Name)Target Disease Area Stage Changes

Myrbetriq

Overactive bladder associated with

symptoms of urgency, US Approved Approved in US in June 2012

y q(mirabegron) urinary frequency, and

urge urinary incontinence

US Approved Approved in US in June 2012.

P t tGonax(degarelix)

Prostate cancer

(One-month formulation)Japan Approved Approved in Japan in June 2012.

Filed FiledCode No.

Generic NameTarget Disease Area Stage Changes

NDA submitted in US in May 2012

MDV3100enzalutamide*

Metastatic castration-resistant prostate cancer who have received docetaxel-

based chemotherapy

USEurope

Filed

2012.-NDA accepted and priorityreview granted in July 2012.

MAA submitted in Europe in June 2012

15

June 2012.*p-INN (proposed international nonproprietary name)

NDA: New drug application, MAA: Marketing authorization application

Changes in Pipeline Status Since May 2012<Stage Up and New etc ><Stage Up and New etc.>

Code No.Target Disease Area Stage Changes

Stage up, initiation of new study etc.

Generic NameTarget Disease Area Stage Changes

ASP1585 (AMG223)bixalomer

Hyperphosphatemia in patients not on dialysis with

chronic kidney disease Japan P3

Entered into P3 in Japan(Preparing for initiation of P3 studies) [New indication]

YM060ramosetron

Irritable bowel syndromeFemale patients

Japan P3Entered into P3 in Japan(Preparing for initiation of P3 studies) [New indication]

YM060Irritable bowel syndrome

BioequivalentPreparing for NDA filing based on

YM060ramosetron

(Orally-disintegratingtablet)

JapanBioequivalent

studythe results of bioequivalent study[New formulation]

erlotinib

NSCLC (combination with MetMab） US

P3 Conducting P3 studieserlotinibColorectal Carcinoma

Pediatric EpendymomaEurope

P3 Conducting P3 studies

ASP1707 EndometriosisEuropeJapan

P2Entered into P2 in Europe and Japan (Preparing for initiation of

JapanP2 study)

Code No. Target Disease Stage Changes New P1

16

g g g

ASP6432Lower urinary tract symptoms associated

with benign prostatic hyperplasiaP1 Entered into P1

Changes in Pipeline Status Since May 2012 <Discontinuation and “Multi Track R&D”><Discontinuation and Multi-Track R&D > Discontinuation

Code No. Target Disease Stage Reason for DiscontinuationCode No. Target Disease Stage Reason for Discontinuation

ASP5034 Type 2 diabetes P1We have decided to discontinue the development after comprehensive review of P1 study results and competitive situation etc.

Discontinuation in part of indications

Generic Name Target Disease Area Stage Reason for Discontinuation

erlotinib

Non-small cell lung cancer (First line for patients with EGFR mutation, adjuvant, combination with MetMab),

USEurope

P3

Development for the indication of unresectable hepatocelluar carcinoma was discontinued because P3 results showed that addition of erlotinib to sorafenib did not

Hepatocellular carcinoma, Colorectal carcinoma, Pediatric ependymoma

Europe that addition of erlotinib to sorafenib did not improve overall survival (primary endpoint).Development for other indications continues.

Code No. Target Disease Stage Changes-Transferred the assets to Seldar.

Deleted from the pipeline list because we decided not to develop it by ourselves.(We transferred its assets to another company as a part of activities of “Multi-Track R&D”.)

17

ASP7147 Irritable bowel syndrome P1 Drais will conduct further development. -P1 ongoing.

Mirabegron (YM178): Development Progress

Japan: Launched on September 16, 2011p p ,

EU: MAA filed on August 24, 2011

US: NDA filed on August 26, 2011NDA approved on June 28, 2012

Asia: Obtained top line results in multinational P3(China/Korea/Taiwan/India) in April 2012(China/Korea/Taiwan/India) in April 2012-The study met the primary endpoint.

-Mirabegron was well tolerated.

Preparing for NDA filing in some of countries of Asia and Oceania

18

Oncology Pipeline ExpansionP j t T t Ch t i ti P1 P2 P3 Fil dProject Target cancer Characteristics P1 P2 P3 Filed

EnzalutamideMDV3100

Prostate cancer (PC), Breast cancer (BC)

1st androgen receptor signaling inhibitor

PC: Post-chemoPC: Pre-chemoEU/US/Japan/Asia

BC:US

Filed in US/EU

lecu

le

BC:US

TivozanibASP4130

Renal cell carcinoma (RCC), Colorectal cancer (CRC), Breast cancer (BC),

Potent, selective, long half-life inhibitor of VEGF receptors 1, 2 and 3

RCC: EU/US

CRC, BC: EU/US

QuizartinibAC220

Acute myeloid leukemia Potent and selective 2nd

generation FLT3 kinase inhibitor EU/US

Sm

all m

o AC220Acute myeloid leukemia generation FLT3 kinase inhibitor EU/US

Degarelix(Gonax) Prostate cancer 1st GnRH antagonist in Japan

1M formulation: JP

3M: JPSepantronium

YM155Breast cancer,

Non-Hodgikin’s lymphomaFirst-in-class survivinsuppressant EU/US/JP

Approved

YM155 Non-Hodgikin s lymphoma suppressantASP1707 Prostate cancer* Oral GnRH antagonist

ASP3026 Cancer ALK tyrosine kinase inhibitor

ASP9521 Prostate cancer

ASP9603 Prostate cancerASP9603 Prostate cancer

OS

I

Erlotinib(Tarceva)

NSCLC (1st line for patients with EGFR mutation, adjuvant, combination with

MetMab), CRC, Pediatric Ependymoma

HER1/EGFR tyrosine kinaseinhibitor US

LinsitinibASP7487 (OSI-906)

Ovarian cancer, Non-small cell lung cancer

IGF-1R/IR tyrosine kinaseinhibitor US

ASP7487 (OSI-906) Non small cell lung cancer inhibitor

OSI-027 Renal cell cancer mTOR kinase inhibitor US

bo

dy

AGS-1C4D4 Pancreatic cancer Antibody (target: PSCA) EU/USAGS-16M8F/AGS-16C3F

Renal cancer Antibody utilizing ADC(target: ENPP3)

19

An

tib

( g )

ASG-5ME Prostate cancer, Pancreatic cancer Antibody utilizing ADC(target: SLC44A4)

ASG-22ME Solid tumors Antibody utilizing ADC(target: Nectin-4)

*P2 for indication of endometriosis NSCLC: Non-small cell lung cancer

Enzalutamide: Development Progress

Study Target Design P1 P2 P3 Filed

P3Post-chemoPatients with progressive castration- Placebo-

Study completed.NDA in US: May 21, 2012 Filed

EU/US [AFFIRM study]

p gresistant prostate cancer previously treated with docetaxel-based chemotherapy

controlled, n=1,199

y-NDA accepted and priority review granted in July 2012.

MAA in EU: June 26, 2012

P3 ADT failure Placebo- Completed enrollment:P3EU/US/JP/Asia [PREVAIL study]

Chemotherapy-naive patients with progressive metastatic prostate cancer who have failed ADT

Placebocontrolled, n=1,680

May 2012Selected sites in Asia will remain open.

P2 LHRH analogue failure To compare EU/US [TERRAIN study]

gAdvanced prostate cancer patients who have progressed while on LHRH analogue therapy or following surgical castration

with bicalutamide, n=370

Ongoing

C l t dP2EU

Hormone-naiveHormone-naive prostate cancer

Open-label, n=60

Completed enrollment:January 2012

Post-chemoCompletedP1/2

JP

Patients with progressive castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy

Open-label,n=46

Completed enrollment:April 2012

Breast Cancer

20

P1US

Breast CancerBreast cancer patients who have failed prior hormonal therapy

Open-label, n=27

First Patient In: April 2012

ADT: Androgen deprivation therapy, LHRH: Lutenizing hormone-releasing hormone

Tivozanib: Development ProgressStudy Target Design P1 P2 P3 Filed

P3 EU/US

Renal cell carcinomaMonotherapy

Comparing the efficacy and safety of

CompletedEU/US[TIVO-1 study] Pivotal

Monotherapy(Patients with advanced renal cell carcinoma)

efficacy and safety of tivozanib with sorafenib, n=500

P1b Renal cell carcinoma Open-label,C l t d

Preparing for NDA/MAA filing

US Combo with temsirolimusOpe abe ,n=28

Completed

P2EU/US

Colorectal cancer Combo with mFOLFOX6

Comparing the efficacy and safety of

OngoingEU/USversus mFOLFOX6+bevacizumab

tivozanib with bevacizumab, n=252

Ongoing

P2EU/US

Breast cancer Preparing for P2EU/US

Breast cancer p g

P1bUS

Breast cancer and Colorectal cancer Combo with capecitabine

Open-label, n=24 Ongoing

Combo with capecitabine

Other studies in renal cell carcinoma:-TAURUS study (P2 in EU/US): Initiate the study to compare patient preference of a first line

therapy after receiving both tivozanib and sunitinib in sequence

21

therapy after receiving both tivozanib and sunitinib in sequence-BATON-RCC study (P2 in US): Ongoing exploratory biomarker study

Presented the results of TIVO-1 at ASCO in June 2012ASCO: American Society of Clinical Oncology

Ipragliflozin (ASP1941): Development Progress

Recent update of development status▼

Japan: P3 Monotherapy study (24-week open-label) : Initiated

P3P1 P2

P3 (add-on to SU, Pio, -GI and DPP4): Last patient out

Asia: P3 Monotherapy study: Initiated

Initiated (n=145, 24w)Monotherapy(24-week open-label)

Monotherapy(placebo controlled DBT)

Completed (n=129, 16w)

Summary results obtained (n=182, 52w)JP Summary results obtained: Metformin (n=168)

Last patient out: SU (n=225) Pio (n=150) GI (n=100) DPP4 (n=100)

Monotherapy(long term safety)

Add-on studies with otheranti-hyperglycemic drugs (52w)

Completed (n 412 12w)USMonotherapy

SU (n=225), Pio (n=150), -GI (n=100), DPP4 (n=100) Recruitment completed: Nate (n=100)

yp g y g

Long-term renal impairment Recruitment completed (n=150, 52w)

P2b

Add-on study

Completed (n=412, 12w)

Completed (n=343, 12w)EU/US

USDose-finding add-on study with metformin

pydose-finding

Initiated (n=280 24w)

P2b

P2b

22

Monotherapy

ywith metforminAsia*

Initiated (n=280, 24w)

Initiated (n=480, 24w)

SU: sulfonylureas, Pio: pioglitazone, -GI: -glucosidase inhibitor, DPP4: DPP4 inhibitor, Nate: nateglinide*Korea, China, and Taiwan

Ipragliflozin: Results of P3 (Metformin Add-On)in Japan Presented at ADAin Japan, Presented at ADA

Excerpt from the slides presented by Astellas at ADA on June 9, 2012

Mean change from baseline in HbA1c (+SD)▼ ▼Study outline Target: Type 2 diabetes mellitus

Study design treatment arm: Study design, treatment arm: -Double-blind (24 weeks),

ipragliflozin 50 mg or placebo, combination with Metformincombination with Metformin

-Open-label (28 weeks), ipragliflozin 50 mg or 100 mg, combination with Metformin

Treatment duration: 52 weeks

Number of subjects: 168

Primary endpoint: HbA1c Primary endpoint: HbA1c

23

Ipragliflozin (50 mg/day) added to metformin therapy for 24 weeks was well tolerated and significantly reduced HbA1c levels compared with placebo by 1.30%

ADA: American Diabetes Association

FY2012 Progress of Late Phase Compounds

Phase 3 NDA Filing Approvalenzalutamide

Pre-chemo *

PC Launched

quetiapine(Seroquel) acotiamide

DIFICLIR

solifenacinpediatric

isavuconazole

erlotinib

capsaicin(Qutenza)

Mirbetriq

enzalutamidePost-chemo

PC

ASP0113(VCL-CB01)

pediatric

bixalomer(Kiklin)

Not on dialysis

(Tarceva)

Kiklin

Launched

Mirbetriq

mirabegron

beraprostdi

tivozanib certolizumabpegol

RA **

Kiklin

Gonax

certolizumabpegol

MTX-naive RA Launched

Regnite

sodium(Careload) solifenacin/

tamsulosinramosetron

(Irribow)IBS Female

ipragliflozin

24

Japan Europe US EU/USPC: Prostate cancer, RA: Rheumatoid arthritis* EU/US/JP**RA in patients who respond insufficiently to current therapies

Profit Distribution Policy

Top priority on investment for growth of Rx business▼

Dividends to be increased continuously based on mid- and long-term growth▼

Share buybacks to be implemented in a flexible manner▼

FY2011FY2012

(Forecast)

Share buybacks to be implemented in a flexible manner▼

( o ecast)

EPS 169.38 yen 212.16 yen

Dividends per Share 125 yen 130 yenDividends per Share 125 yen 130 yen

ROE 7.7% ―

DOE 5.7% ―

Share Buybacks(*) ―Implemented in a

flexible manner

25

*Excluding amounts for the buyback of shares consisting less than one unit