Outline of Consolidated Financial Results
for the Year Ended March 31, 2019
May 15, 2019NIPPON SHINYAKU CO., LTD.

FY2018 Summary◆ Net sales： 114,716 million yen （+13.1%）◆ Operating profit：

20,644 million yen （+20.9%）◆ Ordinary profit：

21,540 million yen （+23.4%）

Profit attributable：

16,302 million yen （+25.9%）◆ to owners of parent(Million yen)2

Segmental Review - Pharmaceuticals 87,416＋5,468
Revenues from the licensing ofindustrial property rights+6,243+1,094+12,806

100,223（Million yen）
Ethical drugs
Revenues from the licensing ofindustrial property rights

Profit in co-promotion
Net sales

FY2017

YoY Change

FY2018Results

Ratio

Results

Ratio

Amt%

73,07683.6%

78,54478.4%+5,468+7.5%

10,378

11.9%

16,621

16.6%+6,243+60.2%

3,962

4.5%

5,057

5.0%

+1,094+27.6%

87,416100.0%

100,223100.0%+12,806+14.6%

3

Three Main Fields of Focus(million yen)

PAH

Hematology
15,05516,00020,00017,726

Urology

18,036

20,38621,00019,175
17,627

16,175
11,27014,000
8,000

7,489

10,0007,00000FY2016

FY2017FY2018

Uptravi (domestic)

0FY2016

FY2017
VidazaOpsumit (Profit in co-promotion)

GazyvaAdcirca

Others

FY2018FY2016FY2017FY2018

Zalutia

Cialis

Eviprostat

Others4

Segmental Review - Functional Food 14,031+99+12+268+81+461

14,492（Million yen）

FY2017FY2018YoY Change

Results

Ratio

Results

Ratio

Protein preparations

9,454

67.4%

9,554

65.9%

+99+1.1%

Preservatives

2,298

16.4%

2,310

15.9%

+12+0.6%

927

6.6%

1,196

8.3%

+268

+28.9%

Others

1,350

9.6%

1,431

9.9%

+81+6.0%

Net sales

14,031100.0%

14,492100.0%

+461

+3.3%

Health food ingredientsAmt%

5Operating profit
17,079+12,806+461-4,023-2,200-3,479+3,564

20,644（Million yen）

FY2017FY2018YoY Change

Results

Ratio

Results

Ratio

Amt%

101,448100.0%

114,716100.0%+13,268+13.1%(Pharmaceuticals)(87,416)(86.2%)(100,223)(87.4%)(+12,806)(+14.6%)(Functional Food)(14,031)(13.8%)(14,492)(12.6%)(+461)(+3.3%)

Operating expenses

84,368

83.2%

94,07182.0%+9,703+11.5%

Cost of sales

46,92946.3%

50,952

44.4%+4,023+8.6%

SG&A expenses

24,21723.9%

26,41823.0%+2,200+9.1%

R&D expenses

13,221

13.0%

16,701

14.6%+3,479+26.3%

Operating profit

17,07916.8%

20,64418.0%+3,564+20.9%

Net sales

6Profit attributable to owners of parent
12,953＋3,564＋313＋211-739+3,34916,302（Million yen）

FY2017FY2018Results

Results

YoY Change
Amt%

Operating profit

17,07920,644+3,564+20.9%

Non-operating income

1,122

1,435+313+27.9%Non-operating expenses

751539-211-28.1%

Ordinary profit

17,451

21,540+4,089+23.4%

Income taxes, etc

4,497

5,237+739+16.4%

12,953

16,302+3,349+25.9%

Profit attributableto owners of parent

7

Business Forecast for FY2019
YoY Change

FY2018FY2019ResultsForecast

Amt%

Net sales

114,716

116,000+1,284+1.1%

Operating profit

20,64421,000+356+1.7%

Ordinary profit

21,54022,000+460+2.1%

16,302

16,500+198+1.2%（Million yen）

Profit attributableto owners of parent

8

Segmental Forecast - Pharmaceuticals -（Million yen）
Ethical drugs
Revenues from the licensing ofindustrial property rights

Profit in co-promotion
Net sales

FY2018Results

FY2019Ratio

Forecast

YoY Change
Ratio

Amt%

78,54478.4%78,50077.7%-44-0.1%

16,621

16.6%

16,800

16.6%

+179

+1.1%

5,057

5.0%

5,800

5.7%

+743

+14.7%

100,223100.0%

101,100

100.0%

+877

+0.9%

9Segmental Forecast - Functional Food -（Million yen）

FY2018Results

FY2019Ratio

Forecast

YoY Change
Ratio

Amt%

Protein preparations

9,554

65.9%

9,660

64.8%

+106+1.1%

Preservatives

2,310

15.9%

2,470

16.6%

+160

+6.9%

Health food ingredients

1,196

8.3%

1,250

8.4%

+54+2.7%

Others

1,431

9.9%

1,520

10.2%

+89+6.2%

Net sales

14,492100.0%

14,900100.0%

+408

+2.8%

10

Consolidated Statements of Income (Forecast)(Million yen）

FY2018FY2019YoY Change

Results

Ratio

Forecast

Ratio

Amt%

114,716100.0%

116,000

100.0%+1,284+1.1%(Pharmaceuticals)(100,223)(87.4%)(101,100)(87.2%)(+877)(+0.9%)(Functional Food)(14,492)(12.6%)(14,900)(12.8%)(+408)(+2.8%)

Cost of sales

50,95244.4%

51,600

44.5%

+648

+1.3%

SG&A expenses

26,41823.0%

28,30024.4%+1,882+7.1%

R&D expenses

16,701

14.6%

15,10013.0%-1,601-9.6%

Operating profit

20,64418.0%

21,000

18.1%

+356

+1.7%

Non-operating income

1,435

1.3%

1,500

1.3%

+65

+4.5%

Non-operating expenses

539

0.5%

500

0.4%

-39

-7.4%

Ordinary profit

21,54018.8%

22,000

19.0%

+460

+2.1%

Income taxes, etc

5,237

4.6%

5,500

4.7%

+263+5.0%

16,30214.2%

16,500

14.2%

+198

+1.2%

Net sales

Profit attributableto owners of parent

11Dividends Forecast
FY2018FY2019Interim¥29¥43

Annual

¥70

¥86

ＥＰＳ

¥242.04¥244.97

Dividends payout ratio

28.9 ％

35.1 ％

Dividends per share(Yen)8680

Annual70

60

48

Interim52

40

28
2002015

2016

2017

2018

2019

12

Status of Product Pipeline

R&D Compounds (Domestic)
Code No.
(Generic name)<Origin>NS-73(defibrotide)<in-license>
NS-32<in-license>
ZX-008<in-license>

Application
type

NME

Preparation forIndications

developmentPIIPIII

NDA filing

Veno-occlusive disease

New(treatment)
Veno-occlusive disease

indication(prevention)

NME

Iron deficiency anemia

NMEPI

Dravet syndrome
Lennox-Gastaut syndrome
Chronic thromboembolic

NS-304(selexipag)<in-house>

pulmonary hypertension

Newindication

PIII

Arteriosclerosis obliterans

PIII

Lumbar spinal stenosis
NS-580<in-house>
NS-17(azacitidine)<in-license>
NS-065/NCNP-01(viltolarsen)<in-house>
NS-917<in-license>
NS-87<in-license>

NMENewindication

NME

NME
NME

Endometriosis

Acute myeloid leukemia
PIDuchenne muscular

PII

dystrophy
Relapsed/refractory acute
myeloid leukemia

Secondary acute myeloid
leukemia： changes from the third quarter14

R&D Compounds (Overseas)
Code No.

Application(Generic name)type<Origin>prulifloxacin<in-house>
NS-304(selexipag)<in-house>
NS-065/NCNP-01(viltolarsen)<in-house>
NS-018<in-house>

Indications

NME

Bacterial infections

New

Chronic thromboembolic

indication

pulmonary hypertension

NME

NME

Preparation fordevelopment

PIPIIPIII

NDA filing

Duchenne muscular
dystrophy
Myelofibrosis： changes from the third quarter

NS-065/NCNP-01: in the process of a rolling
submission to the U.S. FDA.

15

Reference Materials

Consolidated Statements of Income(Million yen）

FY2017FY2018YoY chenge

Results

Ratio

Results

Ratio

Amt%

101,448100.0%

114,716100.0%+13,268+13.1%(Pharmaceuticals)(87,416)(86.2%)(100,223)(87.4%)(+12,806)(+14.6%)(Functional Food)(14,031)(13.8%)(14,492)(12.6%)(+461)(+3.3%)

Cost of sales

46,92946.3%

50,952

44.4%+4,023+8.6%

SG&A expenses

24,21723.8%

26,41823.0%+2,200+9.1%

R&D expenses

13,221

13.0%

16,701

14.6%+3,479+26.3%

Operating profit

17,07916.8%

20,64418.0%+3,564+20.9%

Non-operating income

1,122

1.1%

1,435

1.3%

+313

+27.9%

Non-operating expenses

751

0.8%

539

0.5%

-211

-28.1%

Ordinary profit

17,451

17.2%

21,54018.8%+4,089+23.4%

Income taxes, etc

4,497

4.4%

5,237

4.6%

+739

+16.4%

12,95312.8%

16,302

14.2%+3,349+25.9%Net sales

Profit attributableto owners of parent

17Consolidated Balance Sheet
End of

End ofYoY Change

End of

End ofYoY Change

FY2017FY2018Amt

FY2017FY2018Amt（Million yen）

Assets155,887

168,763+12,876

Current assets

95,176

110,720+15,544

Fixed assets

60,71058,042-2,668

Liabilities

30,19733,572+3,375Current liabilities

22,45425,406+2,952Long-term liabilities

7,743

8,165

+422

125,689

135,190+9,501

155,887

168,763+12,876

Net assets
Total assets

155,887

168,763+12,876

Total liabilities
and net assets＝Liabilities and Net assets＝＝Assets＝Cash and deposits+10,452

Notes and accounts payable

Notes and accounts receivable+6,388

Income taxes payable+1,481

Securities-1,200Accrued consumption taxes+1,055Inventories-972

Net defined benefit liability+420

Investment securities
Long-term prepaid expenses-2,848Retained earnings-653+12,598-855

18

Consolidated Statements of Cash Flows（Million yen）

FY2017FY2018YoY Change

Results

Results

Amt

Operating activities

6,719

15,310+8,590Investing activities-11,342511+11,854

Financing activities-3,787-3,708+78

27,51039,632+12,122

Cash and cash equivalentsat end of year

+ 6,719+ 15,310+ 511-3,708-11,342-3,787

39,63235,91427,51019

NS-73 (defibrotide)- Treatment of hepatic veno-occlusive disease Development Phase

Japan : NDA filing (treatment)
Japan : PIII (prevention)

Origin[Mar. 2017]
Licensed-in from : Jazz Pharmaceuticals

Development

Nippon Shinyaku in Japan (treatment)
Co-development in Japan :Jazz Pharmaceuticals (prevention)

Mechanism of action

Protective action on vascular endothelium, normalization of
the coagulation/fibrinolysis balanceIndication

Hepatic veno-occlusive disease (VOD)Dosage form

Injection

Feature･VOD is a life-threatening complication which develops inpatients following HSCT, and in severe cases, leading todeath at high rates.
･NS-73 is the only drug for the treatment of VOD (EU/USguideline). It has been launched in 35 countries.
･NS-73 is the only drug for the prevention of VOD.
20

NS-32- Treatment for iron deficiency anemia Development Phase

Japan: PIII

Origin[Dec. 2016]
Licensed-in from: Pharmacosmos A/SDevelopment

Nippon Shinyaku

Mechanism of action

IronIndication

Iron deficiency anemia

Dosage form

IV bolus injection or IV drip infusion

Feature・Can be administered in high doses allowing full iron correctionin the majority of patients・Good safety profile with no dose dependent ADRs
・Minimal potential toxicity from release of labile iron due to tightiron binding in a matrix structure of interchanging isomaltosideand iron・No profound hypophosphatemia
21

ZX008- Treatment for rare intractable epilepsyDevelopment Phase

Japan: PIII

Origin[March. 2019]
Commercial rights from: Zogenix, inc

Development

Zogenix, inc

Mechanism of action

Serotonin agonist

Indication

Dravet Syndrome and Lennox-Gastaut syndrome

Dosage form

Oral agent

Feature・Effective for Dravet syndrome and Lennox-Gastaut syndrome
patients refractory to existing treatment options
・ZX008 can be used in combination with other drugs, asstandard of care for intractable epilepsy is based oncombination therapy.
22

NS-304 (selexipag)- Treatment for pulmonary hypertension, arteriosclerosis obliterans, lumbar spinal stenosis -Development Phase<CTEPH> Japan: PIII
Overseas: PIII
<ASO>
Japan: PIIb
<LSS>Japan: PIIa

OriginNippon Shinyaku

Development

・[Apr. 2008] Licensed-out to (outside Japan):
Actelion Pharmaceuticals Ltd. (Switzerland)
・Co-development in Japan:
Actelion Pharmaceuticals Japan Ltd. (CTEPH)
・Overseas: Johnson-Johnson (CTEPH)
・Nippon Shinyaku (ASO)
・Nippon Shinyaku (LSS)

Mechanism of action

Selective IP receptor agonist

Indication

・Chronic thromboembolic pulmonary hypertension (CTEPH)
・Arteriosclerosis obliterans (ASO)
・Lumbar spinal stenosis (LSS)

Dosage form

TabletFeatureLong-acting oral drug23

NS-580- Treatment for endometriosis Development Phase

Japan: PIIaOrigin

Nippon Shinyaku

Development

Nippon Shinyaku

Mechanism of actionInhibition of membrane-associated prostaglandin E syntase-1

Indication

Endometriosis

Dosage form

Oral agent

FeatureTreatment for endometriosis without hormonal effect and withpossible analgesic potency24

NS-17- Treatment for acute myeloid leukemia Development Phase

Japan: PII

Origin[Oct. 2006]
Licensed-in from :Celgene Corporation

Development

Nippon Shinyaku

Mechanism of action

Inhibition of DNA methylation, Cytotoxic effects

Indication

Acute myeloid leukemia

Dosage form

Injection

Feature・Standard Treatment for acute myeloid leukemia thatineligible for intensive chemotherapy
・Improvement for life prognosis25

NS-065/NCNP-01 (viltolarsen)- Treatment for Duchenne muscular dystrophy -Development Phase

・USA : Rolling submission for NDA(plan to complete NDA in September 2019)
・Japan: PI/II completion(under discussion with regulatory authority for early approval)

OriginCo-development: National Center of Neurology and Psychiatry

Development

Nippon Shinyaku

Mechanism of action

Exon 53 Skipping

Indication

Duchenne muscular dystrophy

Dosage form

Injection

Feature・Improvement in symptoms and prevention of the diseaseprogression by recovery of dystrophin protein expression・Morpholino based oligonucleotide with possible high safety profileand maximized activity
26

NS-917- Treatment for relapsed or refractory acute myeloid leukemia -Development Phase

Japan: Preparation for Clinical Development

Origin[Mar. 2017]
Licensed-in from: Delta-Fly Pharma

Development

Nippon Shinyaku

Mechanism of action

DNA strand-break by incorporating itself into DNAIndication

Relapsed or refractory (r/r) acute myeloid leukemia (AML)

Dosage form

Injection

Feature・Significant anti-leukemic activity with unique mechanism ofaction from other nucleoside analogs at low dose continuousinfusion
・Tolerable safety profile available to elderly patients with r/r
AML27

NS-87- Treatment of secondary acute myeloid leukemia -Development Phase

Japan: Preparation for Clinical Development

Origin[Mar. 2017]
Licensed-in from : Jazz Pharmaceuticals

Development

Nippon Shinyaku

Mechanism of action

Liposomal combination of cytrabine and daunorubicin

Indication

Secondary acute myeloid leukemia (secondary AML)

Dosage form

Injection

Feature・NS-87 is the first therapy for the treatment of secondary
AML in Japan.
・The enhancement of antitumor activity and reducing adverse
events are expected by NS-87 accumulated in bone marrow.

28

Prulifloxacin- Quinolone antibacterial Japan
Licensee・Meiji Seika Pharma Co., Ltd.

Development phase・Launch (Dec. 2002) / Sword® Tablets

Overseas
LicenseeDevelopment phase

・Angelini (Italy)・Approval (Sep. 2004)
・Launch in Italy (Nov. 2004)
・Approval in European countries (Apr. 2005)

・Lee’s Pharmaceutical Holdings Ltd. (Hong Kong)

・NDA filing in China

・Algorithm (Lebanon)

・Launch in Lebanon (Jan. 2012)
・Preparation for launch in 1 country and
NDA filing in 5 countries29NS-018- Treatment for myelofibrosis Development Phase

Overseas (USA): PI/IIOrigin

Nippon Shinyaku

Development

Nippon Shinyaku

Mechanism of action

JAK2 inhibitor

Indication

Myelofibrosis

Dosage form

TabletFeature

・Highly selective for active form of JAK2
・Possibly best-in-class treatment for myelofibrosis

30

Safe Harbor Statement• Materials and information provided during this presentation may contain so-called “forward-lookingstatements.” These statements are based on current expectations, forecasts and assumptions thatare subject to risks and uncertainties which could cause actual outcomes and results to differ materiallyfrom these statements.
• Risks and uncertainties include general industry and market conditions, and general domestic andinternational economic conditions such as interest rate and currency exchange fluctuations. Risks anduncertainties particularly apply with respect to product-related forward-looking statements. Product risks
and uncertainties include, but are not limited to, technological advances and patents attained bycompetitors; challenges inherent in new product development, including completion or failure of clinicaltrials; claims and concerns about product safety and efficacy; regulatory agency’s examination, obtaining
regulatory approvals; domestic and foreign social security reforms; trends toward healthcare cost
containment; and governmental laws and regulations affecting domestic and foreign operations.
• Also, for products that are approved, there are manufacturing and marketing risks and uncertainties, which
include, but are not limited to, inability to build production capacity to meet demand, unavailability of raw
materials, and competition with others.
• The Company disclaims any intention or obligation to update or revise any forward-looking statements
whether as a result of new information, future events or otherwise.
• This English presentation was translated from the original Japanese version.
In the event of any inconsistency between the statements in the two versions, the statements in theJapanese version shall prevail.