08 05-12 astellas presentation-q1

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Financial Results for 1Q/FY 2012 Ending March 31, 2013 August 1, 2012 Yasumasa Masuda Senior Corporate Executive, Chief Financial Officer Astellas Pharma Inc.

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Page 1: 08 05-12 astellas presentation-q1

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Financial Results for 1Q/FY 2012 Ending March 31, 2013

August 1, 2012 Yasumasa Masuda Senior Corporate Executive, Chief Financial Officer Astellas Pharma Inc.

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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.

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1Q/FY2012 Financial Results

1Q/FY11 Actual

1Q/FY12 Actual

Change 2Q/FY12 Forecasts

Progress per 2Q/FY12 Forecasts

Net Sales 251.6 243.2 -3.3% 476.0 51.1% COGs

as % of sales 77.4 30.8%

73.4 30.2%

- -0.6ppt

SG&A Excluding R&D

as % of sales

81.7 32.5%

74.0 30.4%

-9.5%

R&D Expenses as % of sales

43.5 17.3%

42.8 17.6%

-1.5% 86.0 49.8%

Operating Income as % of sales

48.8 19.4%

52.8 21.7%

+8.4% 75.0 70.5%

Ordinary Income 50.3 55.7 +10.7% 75.5 73.8%

Net Income 25.1 35.4 +41.1% 52.0 68.2%

USD 82 80 2 strengthening of YEN

80

EUR 117 103 14 strengthening of YEN

105

●Exchange Rates (Average for the FY; YEN)

Comprehensive Income 14.3 -4.0 -128.5%

Total amortization for OSI and Agensys

•1Q/FY11 8.1 bn YEN (of which OSI: 6.3) •1Q/FY12 6.0 bn YEN (of which OSI: 4.3)

(Billion YEN)

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

-Decrease in income tax burden rate (47.0% → 25.6%)

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1Q/FY2012 Results: Analysis of Change in Sales

Major positive factors Global/Vesicare +0.7 Funguard/Mycamine +0.9 Japan/Micardis [Family] +1.1 Growth of New Product Group +6.5

Celecox, Symbicort, Geninax, Bonoteo, Argamate, Betanis Americas/Scan +0.7

Tarceva +1.0

1Q/FY2011 1Q/FY2012

(Billion YEN)

251.6 243.2

-8.3 [Sales vs. Previous FY] -8.3

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

Major negative factors Grobal/Prograf -2.0 Harnal -3.4 Japan/Lipitor [Family] -5.8 Gaster -1.8 Americas/ Absence of DPP-IV royalty of the

previous year (due to sale of DPP-IV related assets) -2.2

(Billion YEN)

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

Decrease in gross profit: -4.3 <negative factor> Decrease in sales: -8.3 Decrease in COGs ratio: -0.6ppt

-Decreasing factor: Forex impact on elimination of unrealized gain

-Increasing factor: Change in product mix, including impact of change in lipitor contract 48.8

52.8

1Q/FY2011 1Q/FY2012

(Billion YEN) +4.0

[Forex impact: -0.1]

[OP vs. Previous FY] +4.0

Decrease in SG&A excluding R&D expenses: -7.7 <positive factor>

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

Decrease in R&D expenses: -0.6 <positive factor> Impact from the change in depreciation method:

Approx. -1.2

(Billion YEN)

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Japan Europe

Sales by Region (local currency basis)

Americas

Increases in Europe/Asia, Decreases in Japan/Americas

*Calculated based on the location of the seller

Asia

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

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

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

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

-Growth driven mainly by Prograf

1Q/FY12 revenue

(Billion YEN)

YoY (%)

Progress per 2Q/FY12

Forecasts (%)

137.7 -1.2 49.6

1Q/FY12 revenue

(Million EUR)

YoY (%)

Progress per 2Q/FY12

Forecasts (%)

477 +2.0 54.7

1Q/FY12 revenue

(Million USD)

YoY (%)

Progress per 2Q/FY12

Forecasts (%)

579 -1.8 52.8

1Q/FY12 revenue

(Billion YEN)

YoY (%)

Progress per 2Q/FY12

Forecasts (%)

9.9 +9.6 +13.1 excluding

forex impact 52.5

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7.9 7.8

9.9 10.6

7.2 7.6 0.7 0.5

1Q/FY2011 1Q/FY2012 25.9 26.7

0.6

17.2 13.8

1Q/FY2011 1Q/FY2012

Urology: Vesicare, Betanis and Harnal

Asia

Europe

Americas

Japan

(Billion YEN)

43.1 41.1 (-4.6%YoY)

26.7 (+3.1%YoY) 25.9

(Billion YEN) Three Urology Products

Japan: -1% Americas: +8% (USD basis ) Europe: +19% (EUR basis) Asia: -11% (excluding forex impact)

Growth of Vesicare Vesicare

Harnal

Vesicare

Betanis Japan: Launched in Sep. 2011

Top Share in Japan, US and Europe

[YoY]

US (Myrbetriq) Approved in Jun. 2012

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3.1 3.2

2.0 2.2

0.8 1.2 0.4

0.5

11.0 12.4

7.9 7.5

17.2 14.1

3.7 4.4

1.7 1.1

Immunology (Including Transplantation) and Infectious Diseases: Prograf and Funguard/Mycamine

Asia

Europe

Americas

Japan

(Billion YEN) 41.7 39.7 (-4.8%YoY)

7.3 (+14.8%YoY) 6.3

(Billion YEN)

Asia

Europe

Americas

Japan

Prograf

Japan: +12% Americas: -3% (USD basis) Europe: -6% (EUR basis) Asia: +22% (excluding forex impact)

Japan: +6% Americas: +15% (USD basis) Europe: +72% (EUR basis) Asia: +23% (excluding forex impact)

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

Exports

[US] Generics’ share of TRx: 66% (Week of Jul. 20, 2012) Apr. to Jul. cumulative: 65%

1Q/FY2011

[YoY] [YoY]

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

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56 71

42

43

Oncology: Tarceva and Eligard

Tarceva-related Revenues Eligard (Europe)

Combined Tarceva and Eligard revenues grew to 12.8 billion YEN

Non-US revenue

US revenue

(Million USD)

114 (+15.7%YoY)

1Q/FY2012

98

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

31

35 (+12.3%YoY)

(Million EUR)

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Major Products in Japan (excluding global products)

(Billion YEN)

New Product Group

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

21.5 22.6

16.1

22.0

Micardis [family] (Micardis, Micombi, Micamlo)

Symbicort (+31.6%)

(+5.3%YoY) (+36.7% YoY)

Bonoteo (+208.2%) Geninax (+2.3%)

Celecox (+17.4%)

Growth of major products and new product group

9.2 7.9

2.9 2.9

2.2

0.7

6.0

4.5

1.5

Argamate

Lipitor [family] (Lipitor, Caduet)

24.7

18.9 (-23.5%YoY)

1Q/FY2012 1Q/FY2011

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

Kiklin Capsules (Launch: June 2012 in Japan) Indication: Treatment of hyperphosphatemia in patients on dialysis with chronic kidney disease

Regnite Tablets (Launch: July 2012 in Japan) Indication: Treatment of moderate-to-severe primary restless legs syndrome

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

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Jul. 2012: “Horizon Tablets, Powder, Injection” “Sosegon Tablets, Injection” Decided to transfer marketing and manufacturing authorization rights to Maruishi (Effective from Oct. 2012)

Jun. 2012: Partnership with Drais to develop ASP7147 Transferred the assets to Seldar - “Multi-Track R&D” Approach -

Regnite launch

(Restless legs syndrome)

Gonax approval (Prostate cancer)

Myrbetriq approval (Overactive bladder)

Kiklin launch

(Hyperphosphatemia )

Symbicort new dosage and administration

(Adult bronchial asthma, as-needed use in addition to maintenance therapy)

Asia and Oceania Taiwan Febric (febuxostat) launch (May)

JP/US/EU

Singapore Advagraf approval (Apr.)

Combined vaccine approval Quattrovac subcutaneous

injection syringe

Continuous Introduction of New Products and Optimizing Resource Allocation

■ Continuous product introductions (approvals and launches)

■ Optimizing Resource Allocation

DIFICLIR launch (Clostridium difficile infections)

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

Jul. JP Jul. JP

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850

900

950

1,000

1,050

1,100

1,150

FY2010 FY2011 FY2012 FY2013 FY2014

Net sales (Billion YEN)

Forecasts Targets

1,096.0

OP 226.0bn YEN

OP 131.5bn YEN

OP 119.1bn YEN

953.9 969.3

Continuous growth in net sales and OP from the bottom in FY2010

DOE 6% ROE 15%

OP 146.0bn YEN

Continuous growth in sales and OP since the FY2010 low

Overcoming Patent Expiry of Major Products and Posting Sustained Growth

972.0

No change in FY2012 forecasts announced in May 2012

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R&D Pipeline

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Filed P3 P2 P1

Urology ASP7035, ASP0306 ASP4901 (AKP-002) ASP3652 (JP) , ASP6432

Immunology (including Transplantation) and Infectious Diseases

ASKP1240 (JP) ASP2408 ASP2409 ASP4058

Oncology

sepantronium (JP) AGS-16M8F/AGS-16C3F ASG-5ME, ASG-22ME ASP1707(PC, EU) ASP3026, ASP9521 ASP9603 enzalutamide (BC)

Neuroscience ASP0777, ASP8477 ASP9226, ASP6973

DM Complications and Kidney Diseases, Others

ASP7991 ASP1517 (JP) YM311 (JP)

:In-house, additional indication or additional formulation Red: Changes from the previous announcement

Status of Astellas’ Pipeline

acotiamide (FD, JP)

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

ipragliflozin (Diabetes, JP) beraprost (Chronic renal failure, JP/Asia)

isavuconazole (Aspergillosis, candidemia, EU/US)

enzalutamide (PC, Pre-Chemo etc., EU/US/JP/Asia) erlotinib (NSCLC etc., US)

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

ASP1517 (Renal anemia, EU)

ipragliflozin (Diabetes, EU/US)

ASKP1240 (Transplant, US)

ramosetron (IBS Female, JP)

quizartinib (AML, EU/US)

degarelix (3M, JP)

linsitinib (NSCLC etc., US)

solifenacin (Pediatric, EU/US)

diannexin (DGF, US)

PSN821 (Diabetes, Obesity, EU)

OSI-027 (RCC, US)

ramosetron (IBS OD, JP)

sepantronium (BC etc., EU/US)

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

:In-house, new molecular entity :Licensed-in

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

solifenacin/mirabegron (EU)

tivozanib (RCC, EU/US)

ASP7373 (Influenza, JP) ASP7374 (Influenza, JP)

ASP3652 (CP/CPPS etc., EU)

YM311 (Renal anemia, EU)

ASP0113 (SOT, EU/US) ASP0113 (CMV reactivation in HSCT, EU/US)

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

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

certolizumab pegol (MTX-naive RA, JP)

capsaicin (PDN, EU)

linaclotide (IBS, JP)

enzalutamide (PC, Post-Chemo EU/US)

ASP1707 (Endometriosis, EU/JP)

bixalomer (Hyperphosphatemia in patients not on dialysis.JP )

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

Product Name (Generic Name) Target Disease Area Stage Changes

Myrbetriq (mirabegron)

Overactive bladder associated with

symptoms of urgency, urinary frequency, and

urge urinary incontinence

US Approved Approved in US in June 2012.

Gonax (degarelix)

Prostate cancer (One-month formulation)

Japan Approved Approved in Japan in June 2012.

Approved

Filed Code No.

Generic Name Target Disease Area Stage Changes

MDV3100 enzalutamide*

Metastatic castration-resistant prostate cancer who have received docetaxel-

based chemotherapy

US Europe Filed

NDA submitted in US in May 2012. -NDA accepted and priority review granted in July 2012.

MAA submitted in Europe in June 2012.

*p-INN (proposed international nonproprietary name)

NDA: New drug application, MAA: Marketing authorization application

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

Code No. Generic Name Target 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]

YM060 ramosetron

Irritable bowel syndrome Female patients Japan P3

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

YM060 ramosetron

Irritable bowel syndrome (Orally-disintegrating

tablet) Japan Bioequivalent

study

Preparing for NDA filing based on the results of bioequivalent study [New formulation]

erlotinib

NSCLC (combination with MetMab)

Colorectal Carcinoma Pediatric Ependymoma

US Europe P3 Conducting P3 studies

ASP1707 Endometriosis Europe Japan P2

Entered into P2 in Europe and Japan (Preparing for initiation of P2 study)

Stage up, initiation of new study etc.

Code No. Target Disease Stage Changes

ASP6432 Lower urinary tract symptoms associated with benign prostatic hyperplasia P1 Entered into P1

New P1

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

Code No. Target Disease Stage Changes

ASP7147 Irritable bowel syndrome P1 -Transferred the assets to Seldar. Drais will conduct further development. -P1 ongoing.

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”.)

Discontinuation Code No. Target Disease Stage Reason for Discontinuation

ASP5034 Type 2 diabetes P1 We 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), Hepatocellular carcinoma, Colorectal carcinoma, Pediatric ependymoma

US Europe P3

Development for the indication of unresectable hepatocelluar carcinoma was discontinued because P3 results showed that addition of erlotinib to sorafenib did not improve overall survival (primary endpoint). Development for other indications continues.

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Mirabegron (YM178): Development Progress

Japan: Launched on September 16, 2011

Asia: Obtained top line results in multinational P3 (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

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

EU: MAA filed on August 24, 2011

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Oncology Pipeline Expansion Project Target cancer Characteristics P1 P2 P3 Filed

Smal

l mol

ecul

e

Enzalutamide MDV3100

Prostate cancer (PC), Breast cancer (BC)

1st androgen receptor signaling inhibitor

PC: Post-chemo PC: Pre-chemo EU/US/Japan/Asia BC:US

Tivozanib ASP4130

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

Quizartinib AC220 Acute myeloid leukemia Potent and selective 2nd

generation FLT3 kinase inhibitor EU/US

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

1M formulation: JP 3M: JP

Sepantronium YM155

Breast cancer, Non-Hodgikin’s lymphoma

First-in-class survivin suppressant EU/US/JP

ASP1707 Prostate cancer* Oral GnRH antagonist ASP3026 Cancer ALK tyrosine kinase inhibitor ASP9521 Prostate cancer ASP9603 Prostate cancer

OSI

Erlotinib (Tarceva)

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

MetMab), CRC, Pediatric Ependymoma HER1/EGFR tyrosine kinase inhibitor US

Linsitinib ASP7487 (OSI-906)

Ovarian cancer, Non-small cell lung cancer

IGF-1R/IR tyrosine kinase inhibitor US

OSI-027 Renal cell cancer mTOR kinase inhibitor US

Antib

ody AGS-1C4D4 Pancreatic cancer Antibody (target: PSCA) EU/US

AGS-16M8F/ AGS-16C3F Renal cancer Antibody utilizing ADC

(target: ENPP3)

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

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

Filed in US/EU

Approved

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

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Study Target Design P1 P2 P3 Filed

P3 EU/US [AFFIRM study]

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

Placebo-controlled, n=1,199

Study completed. NDA in US: May 21, 2012 -NDA accepted and priority review

granted in July 2012. MAA in EU: June 26, 2012

P3 EU/US/JP/Asia [PREVAIL study]

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

Placebo-controlled, n=1,680

Completed enrollment: May 2012 Selected sites in Asia will remain open.

P2 EU/US [TERRAIN study]

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

To compare with bicalutamide, n=370

Ongoing

P2 EU

Hormone-naive Hormone-naive prostate cancer

Open-label, n=60

Completed enrollment: January 2012

P1/2 JP

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

Open-label, n=46

Completed enrollment: April 2012

P1 US

Breast Cancer Breast cancer patients who have failed prior hormonal therapy

Open-label, n=27

First Patient In: April 2012

Enzalutamide: Development Progress

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

Filed

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Tivozanib: Development Progress Study Target Design P1 P2 P3 Filed

P3 EU/US [TIVO-1 study] Pivotal

Renal cell carcinoma Monotherapy (Patients with advanced renal cell carcinoma)

Comparing the efficacy and safety of tivozanib with sorafenib, n=500

Completed

P1b US

Renal cell carcinoma Combo with temsirolimus

Open-label, n=28 Completed

P2 EU/US

Colorectal cancer Combo with mFOLFOX6 versus mFOLFOX6 +bevacizumab

Comparing the efficacy and safety of tivozanib with bevacizumab, n=252

Ongoing

P2 EU/US Breast cancer Preparing for P2

P1b US

Breast cancer and Colorectal cancer Combo with capecitabine

Open-label, n=24 Ongoing

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 -BATON-RCC study (P2 in US): Ongoing exploratory biomarker study

Preparing for NDA/MAA filing

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

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Monotherapy Add-on study

with metformin

Ipragliflozin (ASP1941): Development Progress

Recent update of development status ▼

Completed (n=412, 12w)

Completed (n=343, 12w)

Summary results obtained (n=182, 52w)

Initiated (n=145, 24w)

JP

EU/US

US Dose-finding add-on study with metformin

Monotherapy dose-finding

Summary results obtained: Metformin (n=168) Last patient out: SU (n=225), Pio (n=150), α-GI (n=100), DPP4 (n=100) Recruitment completed: Nate (n=100)

Monotherapy (24-week open-label) Monotherapy (long term safety)

Add-on studies with other anti-hyperglycemic drugs

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

Asia* Initiated (n=280, 24w)

Initiated (n=480, 24w)

P2b

P2b

SU: sulfonylureas, Pio: pioglitazone, α-GI: α-glucosidase inhibitor, DPP4: DPP4 inhibitor, Nate: nateglinide

Monotherapy (placebo controlled DBT)

Completed (n=129, 16w)

P3 P1 P2

Japan: P3 Monotherapy study (24-week open-label) : Initiated P3 (add-on to SU, Pio, α-GI and DPP4): Last patient out Asia: P3 Monotherapy study: Initiated

(52w)

*Korea, China, and Taiwan

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Mean change from baseline in HbA1c (+SD)

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

Study outline Target: Type 2 diabetes mellitus Study design, treatment arm:

-Double-blind (24 weeks), ipragliflozin 50 mg or placebo, combination 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

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%

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

ADA: American Diabetes Association

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Phase 3 NDA Filing enzalutamide

Pre-chemo *

PC

Approval

ASP0113 (VCL-CB01)

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

DIFICLIR

Regnite

solifenacin pediatric

Launched

FY2012 Progress of Late Phase Compounds

beraprost sodium

(Careload)

quetiapine (Seroquel)

bixalomer (Kiklin)

Not on dialysis

isavuconazole

erlotinib (Tarceva)

tivozanib

acotiamide

solifenacin/ tamsulosin

certolizumab pegol RA **

Kiklin

Gonax certolizumab

pegol MTX-naive RA

capsaicin (Qutenza)

Launched

Launched

Mirbetriq

enzalutamide Post-chemo

PC

mirabegron

ramosetron (Irribow)

IBS Female ipragliflozin

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Profit Distribution Policy

FY2011 FY2012 (Forecast)

EPS 169.38 yen 212.16 yen

Dividends per Share 125 yen 130 yen

ROE 7.7% ― DOE 5.7% ―

Share Buybacks(*) ― Implemented in a flexible manner

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 ▼

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