Outline of Consolidated Financial Results
for the 2nd Quarter Ended September 30, 2020
November 9, 2020
NIPPON SHINYAKU CO., LTD.

1H FY2020 Summary◆ Net sales：

57,817 million yen （+0.8%）◆ Operating profit：

11,140 million yen （+1.0%）◆ Ordinary profit：

11,248 million yen （ -0.2%）

Profit attributable◆ to owners of parent：

8,073 million yen （ -2.6%）（million yen）

2

Segmental Review - Pharmaceuticals 49,817-3,085
Revenues from the licensing ofindustrial property rights+2,345+1,219+479

50,296（Million yen）
Ethical drugs
Revenues from the licensing ofindustrial property rights

Profit in co-promotion
Net sales

1H FY2019

YoY Change

1H FY2020

ResultsRatio

ResultsRatio

Amt%

39,491

79.3%

36,406

72.4%-3,085

-7.8%

7,424

14.9%

9,769

19.4%

+2,345+31.6%

2,901

5.8%

4,121

8.2%

+1,219+42.0%

49,817100.0%

50,296100.0%

+479

+1.0%

Net sales increased by 1.0% through revenues from the licensing of industrial property
rights and profit in co-promotion.
3Segmental Review - Functional Food 7,569+33+95-101
-75
7,521
（Million yen）

1H FY2019-48

1H FY2020

YoY Change

Results

Ratio

Results

Ratio

Amt%

Protein preparations

5,025

66.4%

5,058

67.3%

+33+0.7%

Preservatives

1,176

15.5%

1,271

16.9%

+95+8.1%

Health food ingredients

595

7.9%

493

6.6%

-101

-17.1%

Others

772

10.3%

697

9.3%

-75

-9.8%

Net sales

7,569

100.0%

7,521

100.0%-48-0.6%

Sales from protein preparations and preservatives increased however due to the decrease inhealth food ingredients and other products, net sales decreased by 0.6%.
4Operating profit
11,025+479-48+1,313-536-1,092+114

11,140（Million yen）

1H FY2019

1H FY2020

YoY Change

Results

Ratio

Results

Ratio

57,387100.0%

57,817100.0%

+430

+0.8%

(Pharmaceuticals)(49,817)(86.8%)(50,296)(87.0%)(+479)(+1.0%)(Functional Food)(7,569)(13.2%)(7,521)(13.0%)(-48)(-0.6%)

Operating expenses

46,361

80.8%

46,677

80.7%

+315

+0.7%

Cost of sales

26,30745.8%

24,99443.2%-1,313-5.0%

SG&A expenses

13,48623.6%

14,023

24.3%

+536

+4.0%

R&D expenses

6,567

11.4%

7,659

13.2%

+1,092+16.6%

Operating profit

11,02519.2%

11,140

19.3%

+114

+1.0%

Net sales

Amt%

5Profit attributable to owners of parent
8,291
＋114
-167

+29-194
8,073（Million yen）
Operating profit

1H FY2019

1H FY2020

Results

Results-218
YoY Change
Amt%

11,025

11,140

+114

+1.0%

Non-operating income

767

600

-167

-21.8%

Non-operating expenses

521492-29-5.6%

Ordinary profit

11,271

11,248-23-0.2%

Income taxes, etc

2,980

3,174

+194

+6.5%

8,291

8,073-218-2.6%

Profit attributable toowners of parent

6Business Forecast for FY2020
FY2019(Million yen)

FY2020YoY Change

1H

FY

1H

FY

Results

Results

Results

Forecasts

Net sales

57,387

116,637

57,817

Operating profit

11,025

21,668

Ordinary profit

11,271
8,291

Profit attributable toowners of parent

Amt％

123,000+6,363+5.5%

11,14025,000+3,332+15.4%

22,442

11,24825,500+3,058+13.6%

16,866

8,073

19,000+2,134+12.6%

We look for net sales, operating profit, ordinary profit andprofit attributable to owners of parent to increase year on year.

7Segmental Forecast - Pharmaceuticals FY2019(Million yen)

Ethical drugs
Revenues from the licensing ofindustrial property rights

Profit in co-promotion
Net sales

FY2020YoY Change

1H

FY

1H

FY

Results

Results

Results

Forecasts

39,491

79,81836,406

7,424

15,8602,901
49,817

Amt%

76,800-3,018

-3.8%

9,769

22,500+6,640+41.9%

5,963

4,121

8,400

+2,437+40.9%

101,643

50,296

107,700+6,057+6.0%

Revenues from the licensing of industrial property rights from Uptravi’s
overseas sales and profit in co-promotion will increase our net sales.

8Segmental Forecast - Functional Food FY2019(Million yen)

FY2020YoY Change

1H

FY

1H

FY

Results

Results

Results

Forecasts

Protein preparations

5,025

9,731

5,058

9,680

-51

-0.5%

Preservatives

1,176

2,475

1,271

2,600

+125+5.0%

Health food ingredients

595

1,280

493

1,300

+20+1.5%

Others

772

1,506

697

1,720

+214+14.1%

Net sales

7,569

14,994

7,521

15,300

+306

+2.0%

Amt%

We will enhance our research and development toward newproducts and continue to launch highly valued products withmarket needs to increase our net sales.

9Consolidated Statements of Income (Forecast)
FY2019(Million yen)

FY2020YoY Change

1H

FY

1H

FY

Results

Results

Results

Forecasts

57,387

116,637

57,817(Pharmaceuticals)(49,817)(101,643)(Functional Food)(7,569)Amt%

123,000+6,363+5.5%(50,296)(107,700)(+6,057)(+6.0%)(14,994)(7,521)(15,300)(+306)(+2.0%)

26,30753,15524,99450,700-2,455-4.6%(45.8%)(45.6%)(43.2%)(41.2%)

SG&A expenses

13,486

27,81914,02329,800+1,981+7.1%

R&D expenses

6,567

13,994

7,659

17,500+3,506+25.0%

Operating income

11,025

21,668

11,14025,000+3,332+15.4%

Non-operating income

767

1,599

600

1,200-399-25.0%

Non-operating expenses

521

824

492

700

-124

-15.1%

Ordinary income

11,271

22,442

11,24825,500+3,058+13.6%

Income taxes, etc

2,980

5,575

3,174

6,500

+925

+16.6%

8,291

16,866

8,073

19,000+2,134+12.6%Net sales

Cost of sales(Cost of sales ratio)

Profit attributable toowners of parent

10Dividends Forecast
FY2019FY2020Interim¥43¥49

Annual

¥86

¥99

ＥＰＳ

¥250.42¥282.09

Dividends payout ratio

34.3 ％

35.1 ％

Dividends per share(Yen)

99

100

86
80

70

AnnualInterim60

48522016

2017

40
2002018

2019

2020
11

Status of Product Pipeline

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

NS-065/NCNP-01(viltolarsen)<in-house>
NS-17(azacitidine)<in-license>

Preparation fordevelopment

PIPIINewindication

Preparation forNDA

NDA

LaunchPIIPI
NME

PIII

Duchenne muscular dystrophy

PIII
in progress

Acute myeloid leukemia

PIII
not conduct

Chronic thromboembolic pulmonary hypertension
NS-304(selexipag)<in-house>

Newindication

Arteriosclerosis obliterans
Lumbar spinal stenosis

PIII
PIII

NS-32
(ferric derisomaltose)<in-license>
ZX008<in-license>
NS-580<in-house>
NS-87<in-license>
NS-229<in-house>
NS-917<in-license>

NME

NME
NME
New
combination

Iron deficiency anemia
Dravet syndrome
Lennox-Gastaut syndrome
Endometriosis
Secondary acute myeloid leukemia

NME

Inflammatory Diseases

NME

Relapsed/refractory acute myeloid leukemia：Changes from 1st quarter 202013

R&D Compounds (Overseas)
Code No.
(Generic name)<Origin>Application
typePreparation
Indications

forPI

PII

PIII

Launchdevelopment

NS-065/NCNP-01(viltolarsen)

NME

Duchenne muscular dystrophy

New

Chronic thromboembolic pulmonary

indication

hypertension

NME

Myelofibrosis

PIII
in progress<in-house>
NS-304(selexipag)<in-house>
NS-018(ilginatinib)<in-house>：Changes from 1st quarter 202014

Reference Materials

Consolidated Balance Sheet
End ofEnd of 1H

YoY Change

End ofEnd of 1H

YoY Change

FY2019FY2020Amt

FY2019FY2020Amt(Million yen)

Assets175,017

180,453+5,436

Current assets

121,925

125,376+3,450Non-current assets

53,09155,077+1,985

Liabilities

29,256

27,831-1,424Current liabilities

24,96524,333-632

Non-current liabilities

4,290

3,498

-792

145,760

152,621+6,860175,017

180,453+5,436

Net assets
Total Asset

175,017

180,453+5,436

Total liabilities
and net assets＝Liabilities and Net assets＝＝Assets＝Cash and deposits+3,246Notes and accounts payable

Notes and accounts receivable-3,938Accured tax payable

Inventories+4,286

Net defined benefit liability

Investment securities+2,530Retained earnings-988+1,242-782+5,17716

Consolidated Statements of Cash Flows（Million yen）

1H FY2019

1H FY2020

YoY Change

Results

Results

Amt

Operating activities

11,555

8,127-3,428Investing activities-1,860-2,071-211

Financing activities-2,763-2,899-136

46,48347,494+1,011

Cash and cash equivalents
at end of year+ 8,127+ 11,555- 1,860- 2,071- 2,763

46,48339,632

44,298- 2,899

47,49417

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

・Japan: Launch・USA : Launch・global PIII

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

18

NS-17 (azacitidine)- Treatment for acute myeloid leukemia Development Phase

Japan: NDA filingOrigin[Oct. 2006]
Licensed-in from: Celgene CorporationDevelopment

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 prognosis

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

OriginNippon Shinyaku

Development

・Co-development in Japan:
Janssen Pharmaceutical K.K. (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 drug20NS-32 (ferric derisomaltose)- 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 epilepsy Development 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 liquid 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 on
combination therapy.
22NS-580- Treatment for endometriosis Development Phase

Japan: PIIaOrigin

Nippon Shinyaku

Development

Nippon Shinyaku

Mechanism of action

Inhibition of membrane-associated prostaglandin E synthase-1

Indication

Endometriosis

Dosage form

Oral agent

FeatureTreatment for endometriosis without hormonal effect and withpossible analgesic potency

23NS-87- Treatment for secondary acute myeloid leukemia -Development Phase

Japan: 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 formInjectionFeature

・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.

24NS-229- Treatment for inflammatory diseases Development Phase

Japan: PIOrigin

Nippon Shinyaku

Development

Nippon Shinyaku

Mechanism of action

JAK1 inhibitor

Indication

Inflammatory diseases

Dosage form

Oral agent

Feature・Potent and highly selective JAK1 inhibitor
・High efficacy and good safety profiles are expected in thetreatment for inflammatory diseases

25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, Inc.

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/rAML26NS-018 (ilginatinib)- Treatment for myelofibrosis Development Phase

Overseas (USA): PI/II

OriginNippon Shinyaku

Development

Nippon Shinyaku

Mechanism of action

JAK2 inhibitor

Indication

Myelofibrosis

Dosage form

TabletFeature・Potent and highly selective JAK2 inhibitor
・High efficacy and safety are expected for myelofibrosis (MF)patients with low platelet count, for whom QOL improvement
can’t be obtained because no treatment is available

27

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, which
include, but are not limited to, inability to build production capacity to meet demand, unavailability of rawmaterials, 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.