Outline of Consolidated Financial Results
for the 1st Quarter Ended June 30, 2019
August 7, 2019NIPPON SHINYAKU CO., LTD.

1Q FY2019 Summary◆ Net sales：

29,391 million yen （+5.7%）◆ Operating profit：

6,453 million yen （+33.1%）◆ Ordinary profit：

6,585 million yen （+23.8%）

Profit attributable：

4,951 million yen （+24.9%）◆ to owners of parent(Million yen)2

Segmental Review - Pharmaceuticals 24,060＋734
Revenues from the licensing ofindustrial property rights+730+127
25,652（Million yen）
Ethical drugs
Revenues from the licensing ofindustrial property rights

Profit in co-promotion
Net sales

1Q FY2018+1,592YoY Change

1Q FY2019

ResultsRatio

Results

Ratio

Amt%

19,63081.5%

20,365

79.4%

+734

+3.7%

3,092

12.9%

3,822

14.9%

+730

+23.6%

1,337

5.6%

1,464

5.7%

+127

+9.6%

24,060100.0%

25,652100.0%+1,592+6.6%

Net sales increased by 6.6% through growth of new products, revenues
from the licensing of industrial property rights and profit in co-promotion.
3Three Main Fields of Focus(million yen)

PAH

Hematology

20,00018,20020,57021,000Progress for2019 1H
51.0%

10,000Progress for2019 1H
52.3%

10,22010,500

5,166

5,340

1Q
FY2018

1Q

4,006

00
1Q

10,22010,500

5,480

4,463

0
1Q
FY201820,01021,000Progress for2019 1H
53.6%

8,750

3,875

Urology

1H
FY
forecast forecast

1Q
FY2018FY2019Uptravi (domestic)

VidazaOpsumit (Profit in co-promotion)

GazyvaAdcirca

Others1Q

1H
FY
forecast forecast

FY20191H
FY
forecast forecast

FY2019
Zalutia

Cialis

Eviprostat

OthersSales in the focus fields have smoothly progressed toward 1H forecasts.
4Segmental Review - Functional Food 3,738-27+6-4+26

3,739（Million yen）

1Q FY2018+01Q FY2019

YoY Change

Results

Ratio

Results

Ratio

2,519

67.4%

2,491

66.6%

-27-1.1%

Preservatives

563

15.1%

570

15.3%

+6+1.2%

Health food ingredients

281

7.5%

277

7.4%

-4-1.6%

Others

373

10.0%

400

10.7%

+26+7.1%

Net sales

3,738

100.0%

3,739

100.0%+0+0.0%Protein preparations

Amt%

5Operating profit
4,846+1,592+0-80-3+96+1,606

6,453（Million yen）

1Q FY2018

1Q FY2019

YoY Change

Results

Ratio

Results

Ratio

Amt%

27,798100.0%

29,391100.0%+1,593+5.7%(Pharmaceuticals)(24,060)(86.6%)(25,652)(87.3%)(+1,592)(+6.6%)(Functional Food)(3,738)(13.4%)(3,739)(12.7%)(+0)(+0.0%)

Operating expenses

22,951

82.6%

22,93878.0%-12-0.1%

Cost of sales

13,22047.6%

13,300

45.3%

+80

+0.6%

SG&A expenses

6,665

24.0%

6,668

22.6%

+3+0.1%R&D expenses

3,065

11.0%2,969

10.1%-96-3.2%

Operating profit

4,846

17.4%

6,453

22.0%

+1,606+33.1%Net sales

6Profit attributable to owners of parent
3,964＋1,606-126-214-277
4,951（Million yen）
Operating profit

1Q FY2018

1Q FY2019

Results

Results+987
YoY Change
Amt%

4,846

6,453

+1,606+33.1%

Non-operating income

582

455-126-21.8%

Non-operating expenses

108323+214+197.9%Ordinary profit

5,320

6,585

+1,264+23.8%

Income taxes, etc

1,356

1,634+277+20.5%

3,964

4,951+987+24.9%

Profit attributable toowners of parent

7Business Forecast for FY2019
FY2018(Million yen)

FY20191Q

FY

1Q

Progress

1H

FY

Results

Results

Resultsfor 1H

Forecasts

Forecasts

27,798

114,716

29,391

51.6%

57,000116,000(Pharmaceuticals)(24,060)(100,223)(25,652)(51.7%)(49,600)(101,100)(Functional Food)(3,738)(14,492)(3,739)(50.5%)(7,400)(14,900)

Operating profit

4,846

20,644

6,453

64.5%

10,00021,000Ordinary profit

5,320

21,540

6,585

61.5%

10,70022,0003,964

16,302

4,951

60.4%

8,20016,500

Net sales

Profit attributable toowners of parent

Sales of pharmaceuticals and functional food, and each profit
have progressed toward achievement of 1H, FY forecasts.

8

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

Indications

development

PI

PII

PIII

Sinusoidal obstruction syndrome/
Sinusoidal obstruction syndrome/indication

Veno-occlusive disease (prevention)

NME

Iron deficiency anemia

Preparation
for launching2019.6
ApprovalVeno-occlusive disease (treatment)

New

NME

Preparation for

Dravet syndrome
Lennox-Gastaut syndrome
Chronic thromboembolic pulmonary

NS-304(selexipag)<in-house>

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-87<in-license>
NS-917<in-license>

NME
New
indication

Endometriosis

Acute myeloid leukemia
PINME

Duchenne muscular dystrophy

NME

Secondary acute myeloid leukemia

NMEPII

Preparation
for PI/IIRelapsed/refractory acute myeloid
leukemia： changes from the Fiscal Year Ended March 31, 2019 10

R&D Compounds (Overseas)
Code No.
(Generic name)<Origin>prulifloxacin<in-house>
NS-304(selexipag)<in-house>
NS-065/NCNP-01(viltolarsen)<in-house>
NS-018<in-house>

Application
typeIndications

NME

Bacterial infections

New

Chronic thromboembolicindication

pulmonary hypertension

NME

NME

Preparation fordevelopment

PI

PII

PIII

NDA filing

Duchenne muscular
dystrophy
Myelofibrosis

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

11

Reference Materials

Consolidated Balance Sheet
End ofEnd of 1Q

YoY Change

End ofEnd of 1Q

YoY Change

FY2018FY2019Amt

FY2018FY2019Amt(Million yen)

Assets168,763

168,934+170

Current assets

110,720

110,657-63

Fixed assets

58,04258,276+233

Liabilities

33,572

32,626-945

Current liabilities

25,406

24,846-560

Long-term liabilities

8,165

7,780

-385

135,190

136,307+1,116

168,763

168,934+170

Net assets
Total Asset

168,763

168,934+170

Total liabilities
and net assets＝Liabilities and Net assets＝＝Assets＝Cash and deposits+332Notes and accounts payable+549

Notes and accounts receivable-481

Accounts payable-883

Securities-490

Income taxes payable-1,698Inventories-168

Provision for bonuses+1,451Retained earnings+2,189Investment securities-1,664Long-term prepaid expenses

+959

13

NS-73 (defibrotide)- Treatment of hepatic sinusoidal obstruction syndrome Development Phase

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

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

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

Mechanism of action

Protective action on vascular endothelium, normalization of thecoagulation/fibrinolysis balance

Indication

Sinusoidal obstruction syndrome (SOS)/
Veno-occlusive disease (VOD)

Dosage form

Injection

Feature･SOS/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 SOS/VOD (EU/USguideline). It has been launched in various countries.
･NS-73 is the only drug for the prevention of SOS/VOD.
14

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

Japan: Preparation for PI/IIOrigin[Mar. 2017]
Licensed-in from : Jazz Pharmaceuticals

Development

Nippon Shinyaku

Mechanism of action

Liposomal combination of cytarabine 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.

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 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 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.