fy2017 business results · vaccines make u.s. usiness mtp’s second business pillar (following the...

田辺三菱製薬株式会社

FY2017 Business Results(April, 2017 - March, 2018)

Mitsubishi Tanabe Pharma Corporation

Masayuki MitsukaPresident and Representative Director

May 10, 2018

1

FY2017 Business Results

FY2017 Financial Results

2


FY2017 FY2016 Increase/decreaseFull year

forecasts*

Billion yen Billion yen Billion yen ％ Billion yen

Revenues(Domestic sales revenue)

(Overseas sales revenue)

Overseas sales ratio

433.8320.8

112.926.0%

423.9320.3

103.624.4%

+9.8+0.5

+9.3

+2.3+0.2

+9.0+1.6

433.0324.6

108.325.0%

Cost of sales 169.7 164.3 +5.3 +3.3 169.5Sales cost ratio 39.1% 38.8% +0.3 39.1%

Gross profit 264.1 259.5 +4.5 +1.7 263.5Core operating profit 78.5 94.5 -15.9 -16.9 80.0Operating profit 77.2 94.0 -16.7 -17.9 81.0Net profit attributable to

owners of the Company 57.9 71.2 -13.3 -18.7 63.5

Average exchange rate(USD) ¥110.70 ¥108.72 ¥110.00

•Revenue increased due to increasing sales of high-priority products in domestic ethical drugs and the launch of Radicava in the U.S., etc.

•Core operating profit decreased due to increasing in SG&A expenses of Radicava and R&Dexpenses.

Revenue Trends

3


423.9 433.8

9.6 15.8

1.9 10.6

3.8

3.0

380.0

390.0

400.0

410.0

420.0

430.0

440.0

450.0

460.0

470.0

480.0

FY2016actual

Priorityproducts

Long-listeddrugs

Vaccines Overseasethical drugs

RoyaltyRevenue.etc.

Others FY2017actual

＋

-

‐

Ceredist -1.4

Maintate -1.4

Tanabe Seiyaku

Hanbai products

-7.5

Simponi +7.2

Canaglu +2.1

Canalia +1.8

Lexapro +1.4

Remicade -2.1

Talion -2.0

Domestic ethical drugs

-4.8

Gilenya +3.9

INVOKANA -4.8

Others -2.1

-＋

＋

JEBIK V +1.2

Influenza -2.8

Tetrabik -1.1

Radicava +12.3

JPY b

Cost of Sales, SG&A Expense, Core Operating Profit

4* Negative signs indicate expense and loss


FY2017 FY2016 Increase/decrease

Billion yen Billion yen Billion yen ％

Revenue 433.8 423.9 +9.8 +2.3

Cost of sales 169.7 164.3 +5.3 +3.3Sales cost ratio 39.1% 38.8% +0.3

Gross profit 264.1 259.5 +4.5 +1.7

SG&A expense 104.0 98.3 +5.7 +5.9

R&D expense 79.0 64.7 +14.3 +22.1Amortization of intangible

assets associated with products2.4 1.5 +0.9 +60.4

Other income and expense* 0.0 -0.4 +0.4 -

Core operating profit 78.5 94.5 -15.9 -16.9

• SG&A expenses increased due to the launch of Radicava in the U.S.

• R&D expenses increased by the stage up to the late stage of development and NeuroDerm acquisition

Non-recurring items, Net Profit

5* Negative signs indicate expense and loss


FY2017 FY2016 Increase/decrease



Non-recurring items* -1.2 -0.4 -0.8 -

Operating profit 77.2 94.0 -16.7 -17.9

Financial income 1.8 2.2 -0.3 -15.0

Financial expense 0.4 0.2 +0.1 +70.3

Net profit attributable to

owners of the Company57.9 71.2 -13.3 -18.7

• In Non-recurring items, impairment and restructuring costs were more than the revenue of business capital gains and gain on sales of fixed assets

Medium-Term Management Plan 16-20Achievements in FY2017 and Plans for FY2018

6

Four Strategic Priorities to Open Up the Future

Fiscal 2020 Objectives Revenue ¥500 billion Core operating profit ¥100 billion

Maximizing Pipeline Value Principal results and progress

5 candidates progressing to late stage development trials

✓ MT-2271 (seasonal influenza VLP) Phase3

✓ MT-6548 (renal anemia) Phase3

✓ MT-5547 (osteoarthritis) Phase2/3

✓ MT-5199 (tardive dyskinesia) Phase2/3

✓ ND0612 (Parkinson’s) Phase3(Preparations under way)

Enhancing our pipeline in the field of autoimmune diseases

✓ Acquisition of STNM01 (Stelic Institute & Co.)

Late-stage drug

candidate objective

(including in-licensed

candidates)

10 candidates

R&D investment

(During the period of

the medium-term

management plan)

¥400 billion

1

Strengthening IKUYAKU and Marketing

Principal results and progress

Domestic ethical sales(FY2017) ：¥309.3b

New drugs and priority products sales ratio(FY2017) ：63％

Priority diseases areas:

✓ Growth of Simponi, Tenelia, Canaglu

✓ Approval / launch of Canalia

✓ Launched Rupafin

Others:

✓ Started operations of vaccine manufacturing joint venture, BIKEN

co., Ltd.

Domestic revenue

objective (fiscal 2020)¥300 billion

New drug and priority

product revenue ratio75％

Priority disease areas

Autoimmune | Diabetes and kidney | Central

nervous system | Vaccines

2

7

Achievements in FY2017 and Plans for FY2018

Four Strategic Priorities to Open Up the Future

Accelerating U.S. BusinessDevelopment

Principal results and progress

Launch of Radicava

✓ Solid start

✓ Sales revenue ¥12.3b(FY2017)

✓ Cumulative number of patients who have used Radicava:

2,300 (as of the end of March, 2018)

Acquisition of NeuroDerm

✓ Enhancing the pipeline in neurology in the U.S.

✓ Acquisition procedures completed in October, became wholly

owned subsidiary (total cost approximately ¥120.0 billion)

U.S. revenue objective

(Fiscal Year 2020)¥80 billion

U.S. strategic

investment

(During the period of

the medium-term

management plan)

More than

¥200 billion

3

Reforming Operational Productivity Principal results and progress

Estimate of ¥14.0 billion

✓ ¥4.5 billion in cost of sales and ¥9.5 billion in SG&A expenses

(vs. Fiscal Year 2015)

Number of employees

✓ Consolidated domestic workforce:

6,089 (as the end of March, 2016)

5,158 (as the end of March, 2018 )

(- 931)

Cost of sales / SG&A

expense reduction

objective (Fiscal Year

2020)

Vs. fiscal 2015

¥20 billion

Number of employees

(Fiscal Year 2020)

Consolidated domestic

workforce

5,000 employees

4

8


3rd Step

Sustainedexpansion inU.S. business

2nd Step

Expanding U.S. business

(U.S. strategic investment ofmore than ¥200 billion)

1st Step

Start up the U.S. businessAugust 2017

Launch of Radicava, for the treatment

of ALS (amyotrophic lateral sclerosis)

Neurological disorders

New diseases

Vaccines

Make U.S. Business MTPC’s second business pillar (following the domestic market) by achieving

revenue of ¥80 billion in Fiscal Year 2020 with sustained growth

Roadmap for Accelerating U.S. Business Development3

ND0612

MT-2271

9


¥12.3b

¥31.5b

PayerReimbursement

PhysicianNo. of prescriptions

Understanding Adoption & Penetration of Radicava

FY2017Result

FY2018Plan

Accelerating U.S. Business Development & Radicava business

PatientCompliance

3

10


3P Achievements in FY2017 Plans for FY2018

Physician

- Implemented MR activities⇒Provided information to physicians

• ALS specialists（1st target 270）: 100%• Neurologists

2nd target (1,300):More than 90%3rd target (1,400):More than 60%

- Understanding adoption and penetration of physicians and providing medical information⇒Expand the reach to target Physicians

1st target 3702nd target 1,0003rd target 1,000

Patient

- Supported the therapeutic environment to help patients

⇒Treated number of patients (total) is 2,300⇒ Treatment facility 40%

Infusion center 10%Home Care 50%

- Shortening the lead-time to the start of patient treatment

- Enhancing Support and Nursing care

Payer

- Supported creation of an environment to the enable a smooth start of treatment

- Promoted understanding of Radicava product value by showing clinical data

⇒Medicare approximately 47%; Private insurance approximately 48%; Others 5%

- Promote understanding and knowledge of Radicava product value by post-analysis of the clinical data

Sales ¥12.3b ¥31.5b

Accelerating U.S. Business Development & Radicava business3

11


Maximize the Value of Radicava FY2017 Plans for FY2018

Business regions （indication: ALS）

Switzerland Application accepted Approval expected

Canada ーApplication accepted inAprilApproval expected

EuropeIn discussion with regulatory authorities for filing

Preparation for filing

ASEAN, others Under consideration Under consideration

LCM

(Life Cycle

Management)

Application for 60 mg intravenous infusion bag formulation(Increased convenience with change from 2 bags per administration to 1 bag per administration)

ーApproval expectedPlan to launch in FY2019

Developing MT-1186(New administration route)

ー Plan to initiate Phase1

Accelerating U.S. Business Development Maximize the Value of Radicava


3

12

3 Accelerating U.S. Business Development MT-2271（Medicago）

FY2017 FY2018 FY2019

Adult

AUG.

（U.S.,Europe, Canada, etc. ）

Target Approval

Pediatric 2Q

Phase3

Phase3

MT-2271: Plant-based Seasonal Influenza VLP Vaccine

Apr. : The completion of the Clinical Trial

2Q: Topline data

Filing to FDA


13


2017

3 Accelerating U.S. Business Development MT-2271（Medicago）

Amount of Vaccination

Vaccine derived from egg

Vaccine derived from non-egg

Year

VLP

Cell CultureVaccine

Genetically-modified vaccine

U.S. Market size of Seasonal influenza vaccine : approximately ¥240b

145MM

14

Maximizing Pipeline Value

Product Achievements in FY2017 Plans for FY2018

MT-1303(amiselimod/S1P receptor functional antagonist)

Reevaluated the development plan for in-house development

Promoting activity for the co-operation with other companies

MT-5547(fasinumab/ anti-NGF antibody)

Phase 2/3 initiated(Japan, Osteoarthritis)

Promotion of Phase 2/3

MT-7117(Dermatologicals, etc.)

Phase 1 completedPhase 2 initiated(Oversea, POC achieved)

MT-2990 Phase 1 initiatedPhase 2 initiated(Oversea, POC achieved)

Autoimmune Diseases Area

15




MT-6548(vadadustat/HIF-PH inhibitor)

Phase 3 initiated(Japan, Renal anemia)

Promotion of Phase3Target approval in FY2020

TA-7284（SGLT2 inhibitor）

Promotion of CREDENCE study(Japan, U.S., Europe, etc., Diabetic nephropathy)

Target end of Clinical trial at June, 2019Under consideration for approval the acquisition of diabetic nephropathy

MT-3995(Selective mineralocorticoid receptor antagonist)

Promotion of Phase2(Japan, focused on Non-alcoholic steatohepatitis)

Promoting activity for the co-operation with other companies

Diabetes and kidney diseases Area

16



MT-5199(valbenazine/VMAT2 inhibitor)

Phase 2/3 initiated (Japan, Tardive dyskinesia)

Promotion of Phase 2/3Target approval in FY2021

MT-8554(Nervous system, etc.)

Phase 2 initiated (EU：Painful diabetic peripheral neuropathy)(US：Vasomotor symptoms associated with menopause)

Target POC achieved in Q3, FY2018

ND0612(Levodopa (LD) / Carbidopa (CD))

NeuroDerm Acquisition procedures completed in October, became wholly owned subsidiary(Oct.2017)Promoted the long-term safety study

Phase 3 initiated(U.S., Europe)

MT-1186（Amyotrophic lateral sclerosis/New administration route)

Considering new administration route Phase 1 initiated


CNS Diseases Area

17




MT-2355(DPT-IPV＋Hib)

Promoted Phase 3 (Japan) Promotion of Phase 3

MT-2271(Seasonal influenza

VLP)

Phase 3(adult) initiated(US, EU, Canada, etc.)

Filing in North America in FY2018Target approval in FY2019

Vaccines

18



Progress toward the achievement of the objectives

MT-2355DPT-IPV＋Hib

ND0612Parkinson’s disease

MT-5547Osteoarthritis

MT-5199Tardive dyskinesia

MT-6548Renal anemia

MT-2271seasonal influenza


FY2016 FY2017 FY2018 (Plan)

■：Autoimmune diseases ■：Diabetes and kidney diseases

■：CNS ■：Vaccines

5

10

～～～～

R&D expense

¥ 64.7b

¥79.0b

¥84.5b（plan）

5 candidates

1 candidate

6 candidates

candidates

¥15.5b

¥6.7b

MT-1186ALS／New

administration route

MT-2990Inflammatory diseases /

Autoimmune diseases ,etc.

MT-7117Dermatologicals, etc.

MT-8554Nervous system, etc.



Parkinson’s disease

Renal anemia

seasonal influenza

DPT-IPV＋Hib

Target Approval

10 candidates

FY2020

R&D expensive of

NeuroDerm and Medicago

19



MT-6548Renal anemia

MT-2271seasonal influenza





RemicadeApproval shortened administration interval for CD Maximize share in CD with Stelara

Remicade & Simponi: No.1 share in Bio market (37%share in FY2017)

Expand the share by maximizing the value of i.v. (Remicade) and s.c. (Simponi)

Simponi Insurance coverage of self-injection for rheumatoid arthritis

Expand share through collaboration with Janssen Pharma

Achieved 10% market share in the first year in ulcerative colitis

StelaraStarted co-promotion for an indication of CD with Janssen Pharma


20FY2016 FY2020

New products

Future sales goal:¥150.0 b

FY2018

¥120.5b¥113.8b

FY2017

Additional indication・ Maximize value of i.v. / s.c.

・ New products sales, ¥150.0 billion.

Schem

atic image o

f sales

Autoimmune Diseases Area

20



TeneliaExpanded share by penetration among the

patient with weak kidney and the elderly

Expand share based on good collaboration

with Daiichi Sankyo

Canaglu

Expanded prescription for the heart problem and renal complication of disease case by showing the results of CANVAS trials

Expand share by showing the evidence about the safety and efficacy for the cardiovascular system and kidneys

Canalia Launched Sep. 2017No.1 position in combination drug including both DPP-4 and SGLT2 inhibitor


FY2016 FY2020

Future sales goal¥100.0 bil.

FY2017

¥33.5b ¥41.4b

FY2018

CANVASCanalia launched

New products,LCM

CREDENCE

Schem

atic image o

f sales

・ Strengthen a product line-up in the diabetes and kidney diseases area・ Sales goal of ¥100.0 billion, No. 1 presence in the diseases area

Diabetes and kidney diseases area

21


¥ Billion

• Reducing companywide fixed expenses• Targeting a 5,000-person domestic workforce,

moving ahead with reduction of work and reevaluation of duplicated functionsdomestic workforce:

6,089 (as the end of March, 2016)5,158 (as the end of March, 2018 ) -931

Reinvestment in growth strategies

• FY2017 Result : Reduced ¥14.0b companywide fixed expenses because of cost reduction, restructuring, and natural decrease of personnel, etc. (Target ¥10.0b)

• FY2018 Plan : Targeting to reduce ¥19.0b further promoted cost and SG&A expenses reductions, in addition to the period difference

• Reevaluating procurement methods for

pharmaceutical ingredients

• Increasing productivity by improving production

technologies

8.0

20.0SG&A expenses

Cost of sales

14.0

6.5

1.5

9.5

4.5

12.0

8.0

Reforming Operational Productivity

* Benchmark: fiscal 2015

FY2016

ResultFY2017

ResultFY2018

PlanFY2020

Objectives

1.54.5

19.0

8.06.5

9.5

12.0

22

Forecasts of FY2018

23

Forecasts of FY2018

24

Forecasts of FY2018

FY2018 Forecasts

FY2017Actual

Increase/decrease


Revenue(Domestic sales revenue)(Overseas sales revenue)

Overseas sales ratio

435.0

304.7

130.229.9%

433.8

320.8

112.926.0%

+1.1

-16.1

+17.2

+0.3

-5.0

+15.3

Cost of sales 176.0 169.7 +6.2 +3.7Sales cost ratio 40.5% 39.1%

Gross operation profit 259.0 264.1 -5.1 -1.9Core operating profit 70.0 78.5 -8.5 -10.9Net profit attributable to owners of the Company 47.0 57.9 -10.9 -18.9Average exchange rate（USD） ¥105.00 ¥110.70

• Extending Radicava sales in the U.S will cover the decrease in revenue in domestic ethical drugs and royalty income.

• Sales cost ratio will increase by the impact of NHI drug price revision and the change of the product mix.

Revenue Trends

Forecasts of FY2018

433.8 435.0

9.1

1.4

22.50.9

23.6

9.2

390.0

400.0

410.0

420.0

430.0

440.0

450.0

460.0

470.0

480.0

FY2017actual

Priorityproducts

Long-listeddrugs, etc.

Vaccines Overseasethical drugs

Royaltyrevenue, etc.

Others FY2018forcasts

JPY b

Domestic ethical drugs -13.1

＋

＋

＋

The impact of NHI drug price revision

-21.0

-

Rupafin +6.4Simponi +2.9Canagulu +2.0 Canalia +1.4Talion -9.5Remicade -9.1

-

Kremezin +1.9Maintate -5.0Ceredist -1.4Radicut -1.0Tanabe Seiyaku Hanbai products

-6.69.1

18.7

9.5

Except Talion Talion

Talion

Except Talion

＋

Priority Products

＋

Radicava +19.2

＋

25

-

0.0

30.0

60.0

90.0

FY2016FY2017

FY2018 forcasts

53.7 57.7

18.8 13.9

9.67.4

JPY b79.1

82.2

69.8

Impact of exchange rate fluctuations（yoy）：-¥3.1b

Royalty revenue, etc.

Forecasts of FY2018

Others

INVOKANA/ INVOKAMET

Gilenya

Including ¥5.6b of revenue recognition at once of deferred revenue on MT-1303

<Average exchange Rate (USD)>¥108.72 ¥110.70 ¥105.00

26

Forecasts of FY2018

27

Forecasts of FY2018

* Negative signs indicate expense and loss

FY2018

forecasts

FY2017

actualIncrease/decrease


Revenue 435.0 433.8 +1.1 +0.3

Cost of sales 176.0 169.7 +6.2 +3.7Sales cost ratio 40.5% 39.1%

Gross operating profit 259.0 264.1 -5.1 -1.9

SG&A expenses 101.0 104.0 -3.0 -2.9

R&D expenses 84.5 79.0 +5.4 +6.8Amortization of intangible

assets associated with products 3.0 2.4 +0.5 +22.4

Other income and expense* -0.5 0.0 -0.5 -


• Core operating profit will decrease due to an increase R&D expenses in the late-stage drug development

Forecasts of FY2018

28

Forecasts of FY2018

* Negative signs indicate expense and loss

FY2018

forecasts

FY2017

actualIncrease/decrease



Non-recurring items* -3.0 -1.2 -1.7 -

Operating profit 67.0 77.2 -10.2 -13.3

Net profit attributable to

owners of the Company47.0 57.9 -10.9 -18.9

• Restructuring cost in liquidating assets incurred in non recurring costs

Shareholders Return

29

40 42 4652 56 56

10

49.459.6

45.740.9

63.9 66.8

40.547.6

38.8

-80.0

-60.0

-40.0

-20.0

0.0

20.0

40.0

60.0

80.0

0

10

20

30

40

50

60

70

80

FY2013 FY2014 FY2015 FY2016 FY2017 FY2018

Commemorative dividendDividendsDividends payment ratioDividends payment ratio (prior to amortization of goodwill)

（JPY）（％）

MTPC’s basic policy calls for providing a stable and continuous return to shareholders while striving to maximize enterprise value by aggressively investing in future growth.In mid-term management plan 16-20, implementation of dividends based on mid., long-term profit growth and the dividend policy of the consolidated dividend payout ratio to 50% (IFRS).

A-year-end dividend for FY2017 is ¥28 per share as expected.

Dividends Trends

Shareholders Return

JGAAP IFRS 30

commemorative

dividend

Year-end of

dividend

28

Main IR Event of FY2018

31

Main IR Event of FY2018

• The end of July 2018 Announcement of Financial results 1Q

• The end of Oct. 2018 Announcement of Financial results 2Q

• November 20, 2018 Business briefing session for investors

in Tokyo

• The beginning of Feb. 2019

Announcement of Financial results 3Q

32

Appendix

34

FY2017 FY2016 Increase/decrease *Ｆｏｒｅｃａｓｔｓ Achieved

Billion yen Billion yen Billion yen ％ Billion yen ％

Revenue 433.8 423.9 +9.8 +2.3 433.0 100.2

(Overseas revenue) 112.9 103.6 +9.3 +9.0 108.3 104.3

Domestic ethical drugs 309.3 314.2 -4.8 -1.5 315.4 98.1

Overseas ethical drugs 38.5 22.6 +15.8 +70.0 32.4 118.7

Royalty revenue, etc. 79.1 82.2 -3.0 -3.8 80.2 98.6

OTC 3.7 3.4 +0.3 +9.3 4.1 89.0

Others 3.0 1.4 +1.6 +113.9 0.9 306.3

Details of Revenue

*: Forecasts of FY2017 announced on Oct. 24, 2017. 35

Appendix

FY2017 FY2016 Increase/decrease *Ｆｏｒｅｃａｓｔｓ Achieved

Billion yen Billion yen Billion yen ％ Billion yen ％

Remicade 64.6 66.8 -2.1 -3.2 64.7 100.0Simponi 32.1 24.9 +7.2 +29.0 30.3 105.9Tenelia 17.5 16.5 +0.9 +5.8 1 19.1 91.7Talion 16.9 18.9 -2.0 -10.7 20.8 81.4Lexapro 12.7 11.2 +1.4 +13.2 12.9 98.8

6.9 80.8Canaglu 5.6 3.4 +2.1 +60.8

Imusera 4.7 4.9 -0.1 -3.5 5.1 92.7

Total of priority products 154.4 146.9 +7.4 +5.1 159.9 96.5

（New Product) Canalia 1.8 ― +1.8 ― N/A －Rupafin 0.4 ― +0.4 ― N/A －

Influenza vaccine 9.9 12.7 -2.8 -22.2 10.0 99.1Tetrabik 8.7 9.9 -1.1 -12.0 9.2 95.1Varicella vaccine 5.2 5.4 -0.1 -3.2 5.7 91.8JEBIK V 5.2 3.9 +1.2 +30.4 4.9 104.8Mearubik 5.0 5.9 -0.8 -15.0 5.2 95.1Total of vaccines 35.0 38.9 -3.8 -10.0 36.1 97.2Total 189.4 185.9 +3.5 +1.9 196.0 96.6

*: Forecasts of FY2017 announced on Oct. 24, 2017.

Domestic Ethical DrugsRevenue of Priority Products and Vaccines

Appendix

36

FY2018forecasts FY2017 Increase/decrease

Billion yen Billion yen Billion yen %

Remicade 55.5 64.6 -9.1 -14.1Simponi 35.0 32.1 +2.9 +9.2Tenelia 17.0 17.5 -0.4 -2.8Lexapro 13.1 12.7 +0.3 +3.1Canaglu 7.6 5.6 +2.0 +36.5Talion 7.3 16.9 -9.5 -56.6Rupafin 6.8 0.4 +6.4 +1,464.8Imusera 4.9 4.7 +0.2 +5.4Canalia 3.2 1.8 +1.4 +79.6Total of priority products 150.9 156.6 -5.6 -3.6

Influenza vaccine 11.2 9.9 +1.2 +12.8

Tetrabik 9.1 8.7 +0.3 +4.2

Varicella vaccine 5.5 5.2 +0.2 +4.2

Mearubik 5.5 5.0 +0.5 +11.1

JEBIK V 4.3 5.2 -0.8 -17.1

Total of vaccines 36.5 35.0 +1.4 +4.2

Total 187.5 191.7 -4.2 -2.2

Forecasts of Revenue of Priority Products and VaccinesDomestic Ethical Drugs

37

Appendix

56

195

322

439517 537

577

0

100

200

300

400

500

600

700

FY2011 FY2012 FY2013 FY2014 FY2015 FY2016 FY2017

MTPC royalty revenue

Gilenya worldwide sales by Novartis in Q1 FY2018 (January to March, 2018) : $821 m

($722m, the same period of previous year)

MTPC royalty revenue in FY2017: ¥57.7 b

383727

10231190

14971683 1709

416

111

468

911

1287

1279

1426 1476

405

0

500

1000

1500

2000

2500

3000

3500

2011 2012 2013 2014 2015 2016 2017 Q12018

Gilenya

worldwide sales by NovartisU.S. RoW

(USD m)

Gilenya

(JPY b)

38

Appendix

9.8

20.618.8

13.9

0.0

5.0

10.0

15.0

20.0

25.0

FY2014 FY2015 FY2016 FY2017

MTPC royalty revenueJPY b

278

318340

372

325

383

328

371

284 295265 267

248

0

100

200

300

400

20151Q 2Q 3Q 4Q

20161Q 2Q 3Q 4Q

20171Q 2Q 3Q 4Q

20181Q

INVOKANA/INVOKAMET

worldwide sales by J＆J

USD m

INVOKANA/INVOKAMET

INVOKANA/INVOKAMET worldwide sales by Johnson & Johnson in Q1 FY2018 (January to March, 2018) : $248m(the same period of previous year : $284m)

INVOKANA/INVOKAMET TRx share 6.0% in defined U.S. T2D market MTPC royalty revenue in FY2017 : ¥13.9b

39

Appendix

Pipeline Status

Phase 1

■ MT-7529

Prophylaxis of H7N9 influenza

■GB-1057

Blood and blood forming organs

■MP-124Nervous system

■MT-0814

Ophthalmologicals■MT-7117

Dermatologicals, etc.■MT-4129

Cardiovascular system, etc.■MT-2990

Inflammatory diseases /Autoimmune diseases , etc.

■MT-2765

Cardiovascular system, etc.

■ND0701Parkinson's disease

■ MT-1186Amyotrophic lateral sclerosis(New administration route)

■MT-1303 (EU)

Multiple sclerosis, Psoriasis■MT-1303 (JP, EU)

Crohn’s disease■MP-513 (EU)

Type2 diabetes mellitus■MT-3995 (JP, EU)

Diabetic nephropathy■MT-8972 (Canada)

Prophylaxis of H5N1 influenza

■MT-3995 (JP)

NASH■MT-8554 (EU)

Painful diabetic peripheralneuropathy

■ND0612 (US, EU)Parkinson's disease

■ND0801 (Israel)CNS Disease Cognition disorders

■MT-8554 (US)Vasomotor symptomsassociated with menopause

■Canaglu (Global clinical study)*1

Diabetic nephropathy■MP-513 (China)

Type2 diabetes mellitus■MT-2355 (JP) *2

5 combined vaccine

(4 combined + Hib)

■ MT-2271 (US, EU, Canada, etc.)

Prophylaxis of seasonal influenza■MT-5199 (JP)

Tardive dyskinesia■MT-6548 (JP)

Renal anemia■MT-5547 (JP)

Osteoarthritis

■MP-513 (Indonesia)

Type2 diabetes mellitus■TA-7284 (Indonesia)

Type2 diabetes mellitus■MP-214 (Korea, Taiwan)

Schizophrenia■MCI-186 (Switzerland)

Amyotrophic lateral sclerosis■Valixa (Japan)

Prevention of cytomegalovirusdisease in pediatric organtransplant patients

■MCI-186 (Canada)Amyotrophic lateral sclerosis

Disease area■：Autoimmune disease ■：Diabetes and kidney disease■：CNS disease ■：Vaccines ■：Other

*1: Sponsor: Janssen Research & Development, LLC

*2: Co-developed with The Research Foundation for Microbial Diseases of Osaka University (JP)

As of Apr. 30, 2018Red: Progress after Feb. 5, 2018, the financial results for Q3 FY2017

Phase 2 Phase 3 Filed Approved

■Novastan (China)

Acute cerebral thrombosis

■TA-7284 (US, EU)Reduce the risk of death in Type 2 diabeteswith established, or risk for, cardiovascular disease (CANVAS/CANVAS-R)

■FTY720 (US, EU)Pediatric multiple sclerosis

File

d

Ph

ase

3

■ TA-7284 (Global clinical study)*1

Diabetic nephropathy

■MT-4580 (JP)Hypercalcemia in Patients with Parathyroid Carcinoma or Primary Hyperparathyroidism■MT-210 (US, EU)

Schizophrenia

Major license-out products

(post Phase 3)

■MT-4580 (JP)Secondary hyperparathyroidism in chronic kidney disease patients on maintenance dialysis

Ap

pro

ved

40

Appendix

Cautionary Statement

The statements contained in this presentation is based on a numberof assumptions and belief in light of the information currently availableto management of the company and is subject to significantrisks and uncertainties.

41

fy2017 business results · vaccines make u.s. usiness mtp’s second business pillar (following the...

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