Going beyond it all, to the future of medicine.

Outline of Consolidated Financial Results
for the 1st Quarter Ended June 30, 2018
August 7, 2018
NIPPON SHINYAKU CO., LTD.

1Q FY2018 Summary◆ Net sales： 27,798 million yen （+14.8%）◆ Operating profit：

4,846 million yen （-3.3%）◆ Ordinary profit：

5,320 million yen （-1.1%）

Profit attributable：

3,964 million yen （+0.1%）◆ to owners of parent(Million yen)2

Segmental Review - Pharmaceuticals 20,814＋1,905
Revenues from the licensing ofindustrial property rights+943+396
24,060（Million yen）
Ethical drugs
Revenues from the licensing ofindustrial property rights

Profit in co-promotion
Net sales

1Q FY2017

YoY Change

1Q FY2018

ResultsRatio

ResultsRatio

Amt%

17,72485.2%

19,63081.5%+1,905+10.8%

2,148

10.3%

3,092

12.9%

+943

+43.9%

940

4.5%

1,337

5.6%

+396

+42.1%

20,814100.0%

24,060100.0%+3,245+15.6%

3

Three Main Fields of Focus(million yen)

PAH

Hematology

Urology

14,90015,70016,00015,000Progress for2018 1H
54.2%

10,0007,1505,000

7,695

8,000

4,348

3,876

0

5,00001Q
FY2017

1Q

1H
FY
forecast forecast

Progress for2018 1H
55.1%

9,370

10,000

4,007

4,000

2,538

18,09015,000Progress for2018 1H
52.1%

12,00020,0004,687

5,16701Q
FY2017FY20181Q

1H
FY
forecast forecast

1Q
FY2017

1Q

1H
FY
forecast forecast

FY2018FY2018

Uptravi (domestic)
Opsumit (Profit in co-promotion)
AdcircaVidazaCylocide

Others

Zalutia

Cialis

Eviprostat

Others4Segmental Review - Functional Food 3,398+215+13+84+263,738（Million yen）

1Q FY2017

YoY Change

1Q FY2018

Results

Ratio

Results

Ratio

Amt%

2,303

67.8%

2,519

67.4%

+215+9.4%

Preservatives

550

16.2%

563

15.1%

+13+2.4%

Health food ingredients

197

5.8%

281

7.5%

+84+42.7%

Others

346

10.2%

373

10.0%

+26+7.7%

Net sales

3,398

100.0%

3,738

100.0%+340+10.0%

Protein preparations

5

Operating profit
5,012+3,245+340-2,094-793-863
4,846（Million yen）

1Q FY2017

1Q FY2018

YoY Change

Results

Ratio

Results

Ratio

Amt%

24,212100.0%

27,798100.0%+3,585+14.8%

Pharmaceuticals

20,81486.0%

24,06086.6%+3,245+15.6%

Functional Food

3,398

14.0%

3,738

13.4%

+340

+10.0%

Operating expenses

19,20079.3%

22,951

82.6%+3,751+19.5%

Cost of sales

11,12546.0%

13,22047.6%+2,094+18.8%

SG&A expenses

5,872

24.2%

6,665

24.0%

+793

+13.5%

R&D expenses

2,202

9.1%

3,065

11.0%

+863

+39.2%

Operating profit

5,012

20.7%

4,846

17.4%

-165

-3.3%

Revenue
Net sales

6Profit attributable to owners of parent
3,959-165＋135-30+66
3,964
1Q FY2017

1Q FY2018

Results

Results

5,012

4,846-165-3.3%

Non-operating income

447

582+135+30.2%

Non-operating expenses

77108+30+39.5%

Ordinary profit

5,381

5,320-61-1.1%

Income taxes, etc

1,422

1,356-66-4.6%

3,959

3,964+4+0.1%（Million yen）
Operating profit

Profit attributable toowners of the parent

YoY Change
Amt%

7

Business Forecast for FY2018

FY 2017（Million yen）

FY 2018

FY 2018

１QFY

１Q

Progress

1HFYResults

Results

Resultsfor 1HForecast

Forecast24,212

101,448

27,79853.5%

52,000108,000

110,000

Pharmaceuticals

20,81487,41624,06053.6%

44,90093,600-Functional Food

3,398

14,031

3,738

52.7%

7,100

14,400-Operating profit

5,012

17,079

4,846

74.6%

6,500

18,50018,000Ordinary profit

5,381

17,451

5,320

78.2%

6,800

19,000-3,959

12,953

3,964

80.9%

4,900

14,00012,000Net sales

Profit attributable toowners of the parent(5th MMP)

MMP: Medium-Term Management Plan

8

Status of Development Pipeline

R&D Compounds (Domestic)
Code No.
(Generic name)<Origin>Application
typeGA101(obinutuzumab)

NME<in-license>
NS-73(defibrotide)<in-license>

NMENew

Indications

Preparation fordevelopment

PIPIIPIII

Preparation

Preparation

for NDAfor launching

CD20-positive
follicular lymphoma
Veno-occlusive
disease (treatment)
Veno-occlusive

indication disease (prevention)
Chronic thromboembolic

NS-304(selexipag)<in-house>

pulmonary hypertension

New

Arteriosclerosis

indication

obliterans

PIII
PIII

Lumbar spinal
stenosisNS-580<in-house>
NS-17(azacitidine)<in-license>
NS-065/NCNP-01<in-house>
NS-32<in-license>
NS-917<in-license>
NS-87<in-license>

NME

Endometriosis

New

Acute myeloid

indication

leukemia

NME
NME
NME
NME

Duchenne muscular

PI

PIIPI

PII

dystrophy
Iron deficiency
anemiaRelapsed/refractory acute
myeloid leukemia

Secondary acute
myeloid leukemia： changes from the Fiscal Year Ended March 31, 2018 10

R&D Compounds (Overseas)

Code No.

Application<Origin>prulifloxacin

type<in-house>
NS-065/NCNP-01<in-house>
NS-018<in-house>

NME
NME
NME

Indications

Preparation fordevelopment

PI

PII

PIII

Preparation

NDAfor NDA

filingBacterial infectionsDuchenne muscular
dystrophy
Myelofibrosis

11Reference Materials

Consolidated Balance SheetFY2017FY2018YoY Change

FY2017FY2018YoY Change

4Q Results

1Q Results

Amt

4Q Results

1Q Results

Amt

155,887

156,779+892

30,19729,444-753

Current assets

95,176

97,120+1,944Current liabilities

22,45422,032-421

Fixed assets

60,71059,659-1,051Long-term liabilities

7,743

7,412

-331

125,689

127,335+1,645

155,887

156,779+892（Million yen）
AssetsLiabilities

Net assets
Total assets

155,887

156,779+892＝Assets＝Total liabilities
and net assets＝Liabilities and Net assets＝Cash and deposits-1,615

Notes and accounts payable-1,812

Notes and accounts receivable+3,394

Accounts payable-545

Inventories-700

Income taxes payable-392

Total property, plant and equipment-230

Provision for bonuses+1,426

Investments and other assets-791

Retained earnings+2,21213

GA101 (Obinutuzumab)- Treatment for CD20-positive follicular lymphoma -Development Phase

・EU, USA : Approval (Roche)
・Japan : Approval ［Jul. 2018］ (Chugai Pharmaceutical Co., Ltd.)

Origin［Nov. 2012］
Licensed-in from : Chugai Pharmaceutical Co., Ltd.

Development

Co-development in Japan : Chugai Pharmaceutical Co., Ltd.

Mechanism of action

Anti-CD20 monoclonal antibodyIndication

CD20-positive follicular lymphoma (FL)

Dosage form

Injection

FeatureAnti-CD20 monoclonal antibody, increased antibody-dependent
cellular cytotoxicity (ADCC) activity and direct cytotoxicity

14

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

Japan : Preparation for NDA (treatment)
Japan : PIII (prevention)

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

DevelopmentNippon 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.
15

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 causeactual 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 clinical
trials; claims and concerns about product safety and efficacy; regulatory agency’s examination, obtaining
regulatory approvals; domestic and foreign social security reforms; trends toward healthcare costcontainment; and governmental laws and regulations affecting domestic and foreign operations.
• Also, for products that are approved, there are manufacturing and marketing risks and uncertainties, whichinclude, 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.