Going beyond it all, to the future of medicine.

Outline of Consolidated Financial Results
for the 3rd Quarter Ended December 31, 2018
February 6, 2019NIPPON SHINYAKU CO., LTD.

3Q FY2018 Summary◆ Net sales：

87,019 million yen （+12.0%）◆ Operating profit：

16,435 million yen （+7.1%）◆ Ordinary profit：

17,244 million yen （+7.9%）

Profit attributable：

12,698 million yen （+8.9%）◆ to owners of parent(Million yen)2

Segmental Review - Pharmaceuticals 67,003＋3,926
Revenues from the licensing ofindustrial property rights+4,108+759+8,79475,798（Million yen）
Ethical drugs
Revenues from the licensing ofindustrial property rights

Profit in co-promotion
Net sales

3Q FY2017

YoY Change

3Q FY2018

Results

Ratio

Results

Ratio

Amt%

56,01083.6%

59,93679.1%+3,926

+7.0%

7,854

11.7%

11,96315.8%+4,108+52.3%

3,138

4.7%

3,898

5.1%

+759

+24.2%

67,003100.0%

75,798100.0%+8,794+13.1%

3

Three Main Fields of Focus(million yen)

PAH
Progress forFY2018

78.3%

15,00014,900

Hematology

UrologyProgress for
FY2018Progress for
FY201818,00011,67385.9%
13,94220,00018,09015,891

13,48615,00010,00087.8%

15,70014,92812,0008,755

10,000

6,000

5,000

5,000

000
FY20173Q

FY20183Q

FY2018
forecast

FY20173Q

FY20183Q

Uptravi

VidazaOpsumit (Profit in co-promotion)

Cylocide

Adcirca

Others

FY2018
forecast

FY20173Q

FY20183Q

FY2018
forecast

Zalutia

Cialis

Eviprostat

Others4

Segmental Review - Functional Food 10,699+227+31+197+65

11,221（Million yen）

3Q FY2017+521

3Q FY2018

YoY Change

ResultsRatio

Results

Ratio

Amt%

Protein preparations

7,212

67.4%

7,439

66.3%

+227+3.1%

Preservatives

1,782

16.7%

1,814

16.2%

+31+1.8%

657

6.1%

855

7.6%

+197

+30.1%

Others

1,047

9.8%

1,112

9.9%

+65+6.2%

Net sales

10,699100.0%

11,221100.0%

+521

+4.9%

Health food ingredients5Operating profit
15,342+8,794+521-3,769-1,777-2,676+1,093

16,435（Million yen）

3Q FY2017

3Q FY2018

YoY Change

Results

Ratio

Results

Ratio

Amt%

77,703100.0%

87,019100.0%+9,316+12.0%(Pharmaceuticals)(67,003)(86.2%)(75,798)(87.1%)(+8,794)(+13.1%)(Functional Food)(10,699)(13.8%)(11,221)(12.9%)(+521)(+4.9%)

Operating expenses

62,361

80.3%

70,58481.1%+8,223+13.2%

Cost of sales

35,321

45.5%

39,09144.9%+3,769+10.7%

SG&A expenses

17,98723.2%

19,76522.7%+1,777+9.9%

R&D expenses

9,051

11.6%

11,72713.5%+2,676+29.6%

Operating profit

15,342

19.7%

16,43518.9%+1,093+7.1%

Net sales

6Profit attributable to owners of parent
11,660＋1,093＋239-64-231＋1,037

12,698（Million yen）
Operating profit

3Q FY2017

3Q FY2018

ResultsResults

YoY Change
Amt%

15,342

16,435+1,093+7.1%

Non-operating income

969

1,208+239+24.7%

Non-operating expenses

335

399+64+19.1%

Ordinary profit

15,975

17,244+1,268+7.9%

Income taxes, etc

4,314

4,546+231+5.4%

11,66012,698+1,037+8.9%

Profit attributable toowners of the parent

7Business Forecast for FY2018
FY2017(Million yen)

FY2018FY20183Q

FY

3Q

Progress

FY

Results

Results

Resultsfor FY

Forecast

77,703

101,448

87,01980.6%

108,000

110,000(Pharmaceuticals)(67,003)(87,416)(75,798)(81.0%)(93,600)-(Functional Food)(10,699)(14,031)(11,221)(77.9%)(14,400)-

Operating profit

15,342

17,07916,43588.8%

18,50018,000Ordinary profit

15,975

17,451

17,24490.8%

19,000-11,66012,953

12,69890.7%

14,00012,000Net sales

Profit attributable toowners of the parent(5th MMP)

MMP: Medium-Term Management Plan8Status of Product PipelineR&D Compounds (Domestic)
Code No.
(Generic name)<Origin>NS-73(defibrotide)<in-license>
NS-32<in-license>

Application
typeNME

Indications

development

PIPIIPIII

NDA filing

Veno-occlusive
disease (treatment)

New

Veno-occlusive

indicationdisease (prevention)

NME

Preparation forIron deficiency

Preparation
for PIII

anemiaChronic 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(viltolarsen)<in-house>
NS-917<in-license>
NS-87<in-license>

NME

Endometriosis

New

Acute myeloid

indication

leukemia

NME

NME
NME

Duchenne muscular

PI

PII

dystrophy
Relapsed/refractory acute
myeloid leukemia

Secondary acute
myeloid leukemia： change from the 2nd quarter10

R&D Compounds (Overseas)
Code No.

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

NME

NME

NME

Indications

Preparation fordevelopment

PIPII

PIII

NDA filing

Bacterial infections
Duchenne muscular
dystrophy
Myelofibrosis

Nippon Shinyaku has started a rolling submission
for NS-065/NCNP-01 to the U.S. FDA.

11

Reference Materials

Consolidated Balance Sheet
End of

End of 3Q

YoY Change

End of

End of 3Q

YoY Change

FY2017FY2018Amt

FY2017FY2018Amt

155,887

159,486+3,59930,19727,273-2,924Current assets

95,176103,217+8,041

Current liabilities

22,454

20,670-1,783Fixed assets

60,71056,269-4,441Long-term liabilities

7,743

6,602

-1,141

125,689

132,213+6,524

155,887

159,486+3,599(Million yen)
AssetsLiabilities

Net assets
Total assets

155,887

159,486+3,599Total liabilities
and net assets＝Liabilities and Net assets＝＝Assets＝Cash and deposits+2,451

Notes and accounts payable-1,575

Notes and accounts receivable+7,517

Accrued consumption taxes+828

Inventories-1,285

Provision for bonuses-1,424

Net defined benefit liability-1,144Retained earnings+8,993

Property, plant and equipment-469

Investments and other assets-3,915

13NS-32- Treatment for iron deficiency anemia Development Phase

Japan: Preparation for 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
14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
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 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, 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.