Outline of Consolidated Financial Results

for the 3rd Quarter Ended December 31, 2020
February 8, 2021
NIPPON SHINYAKU CO., LTD.

3Q FY2020 Summary◆ Net sales：

91,837 million yen （+4.2%）◆ Operating profit：

20,362 million yen （+31.7%）◆ Ordinary profit：

21,023 million yen （+29.2%）

Profit attributable：

15,085 million yen （+26.9%）◆ to owners of parent(Million yen)2

Segmental Review - Pharmaceuticals 76,665-4,798
Revenues from the licensingof industrial property rights+6,440+1,93680,243（Million yen）
Ethical drugs
Revenues from the licensing ofindustrial property rights

Profit in co-promotion
Net sales

3Q FY2019+3,5783Q FY2020

YoY Change

Results

Ratio

Results

Ratio

Amt%

61,02979.6%

56,23070.1%-4,798-7.9%

11,197

14.6%

17,63722.0%+6,440+57.5%

4,438

5.8%

6,375

7.9%

+1,936+43.6%

76,665100.0%

80,243100.0%+3,578+4.7%

Net sales increased by 4.7% through revenues from the licensing ofindustrial property rights and profit in co-promotion.
3Segmental Review - Functional Food 11,448＋195+123-75-97＋145

11,594（Million yen）

3Q FY2019

3Q FY2020

YoY Change

Results

Ratio

Results

Ratio

Amt%

Protein preparations

7,550

65.9%

7,745

66.8%

+195+2.6%

Preservatives

1,884

16.5%

2,008

17.3%

+123+6.6%

850

7.4%

774

6.7%

-75

-8.9%

Others

1,164

10.2%

1,066

9.2%

-97-8.4%

Net sales

11,448100.0%

11,594100.0%

+145

+1.3%

Health food ingredients4Operating profit
15,466+3,578＋145+2,536-916-447+4,896

20,362（Million yen）

3Q FY2019

3Q FY2020YoY Change

Results

Ratio

Results

Ratio

Amt%

88,113100.0%

91,837100.0%+3,724+4.2%(Pharmaceuticals)(76,665)(87.0%)(80,243)(87.4%)(+3,578)(+4.7%)(Functional Food)(11,448)(13.0%)(11,594)(12.6%)(+145)(+1.3%)

Operating expenses

72,64782.4%

71,47577.8%-1,172-1.6%

Cost of sales

40,68346.2%

38,14641.5%-2,536-6.2%

SG&A expenses

20,952

23.7%

21,869

23.8%

+916

+4.4%

R&D expenses

11,011

12.5%

11,459

12.5%

+447

+4.1%

Operating profit15,466

17.6%

20,36222.2%+4,896+31.7%

Net sales

5Profit attributable to owners of parent
11,886＋4,896＋166-316-1,546+3,19915,085（Million yen）

3Q FY2019

3Q FY2020

Results

Results

YoY Change
Amt%

Operating profit

15,466

20,362+4,896+31.7%

Non-operating income

1,433

1,599

+166

+11.6%

Non-operating expenses

621

938+316+50.9%

Ordinary profit

16,27721,023+4,746+29.2%

Income taxes, etc

4,391

5,938

+1,546+35.2%

11,88615,085+3,199+26.9%

Profit attributable toowners of parent

6Business Forecast for FY2020
FY2019FY20203Q

FY

3Q

Progress

FY

Results

Results

Resultsfor FY

Forecasts

88,113

116,637

91,83774.7%

123,000(Pharmaceuticals)(76,665)(101,643)(80,243)(74.5%)(107,700)(Functional Food)(11,448)(14,994)(11,594)(75.8%)(15,300)

Operating profit

15,466

21,66820,362

81.4%

25,000Ordinary profit

16,27722,442

21,023

82.4%

25,50011,886

16,86615,08579.4%

19,000(Million yen)

Net sales

Profit attributable toowners of parent

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

7

Status of Product Pipeline

R&D Compounds (Domestic)
Code No.
(Generic name)<Origin>NS-065/NCNP-01(viltolarsen)<in-house>
NS-17(azacitidine)<in-license>

Application
typeIndications

Preparation forPIPI

PIIPI
NME

New
indication

PIII

NDA

LaunchPIIPⅢ
in progress

Duchenne muscular dystrophy

Acute myeloid leukemia

Chronic thromboembolic pulmonary hypertension
NS-304(selexipag)

Newindication

Arteriosclerosis obliterans

PIII

Lumbar spinal stenosis<in-house>
New dosePediatric pulmonary arterial hypertension

NME

Iron deficiency anemia

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
New
combination

Dravet syndrome
Lennox-Gastaut syndrome
Endometriosis
Secondary acute myeloid leukemia

NME

Inflammatory diseases

NME

Relapsed/refractory acute myeloid leukemia： Changes from 2nd Quarter 2020
9

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

Preparation fordevelopment

PIPIIPIIILaunch

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>

10Reference Materials

Consolidated Balance Sheet
End of

End of 3Q

YoY Change

End of

End of 3Q

YoY Change

FY2019FY2020Amt

FY2019FY2020Amt(Million yen)

Assets175,017

181,840+6,823Current assets

121,925

127,719+5,793

Non-current assets

53,091

54,120+1,029Liabilities

29,25625,584-3,672Current liabilities

24,96522,391-2,573

Non-current liabilities

4,290

3,192

-1,098145,760

156,256+10,495

175,017

181,840+6,823

Net assets
Total Asset

175,017

181,840+6,823and net assets＝Liabilities and Net assets＝＝Assets＝Cash and deposits

Total liabilities-6,051

Notes and accounts receivable＋ 7,098

Inventories+ 3,794

Investment securities＋ 2,448

Notes and accounts payable-3,519

Income taxes payable＋1,287

Provision for bonuses-1,458Retained earnings+8,88812

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

13

NS-17 (azacitidine)- Treatment for acute myeloid leukemia Development PhaseJapan: NDA filing

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

Nippon Shinyaku

Mechanism of action

Inhibition of DNA methylation, Cytotoxic effects

Indication

Acute myeloid leukemia

Dosage formInjection

Feature・Standard Treatment for acute myeloid leukemia that isineligible for intensive chemotherapy
・Improvement for life prognosis

14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
<Pediatric PAH> Japan: PIIOrigin

Nippon Shinyaku

Development

・Co-development in Japan:
Janssen Pharmaceutical K.K. (CTEPH / Pediatric PAH)
・Overseas: Johnson & Johnson (CTEPH / Pediatric PAH)
・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)・Pediatric pulmonary arterial hypertension (Pediatric PAH)

Dosage form

TabletFeature

Long-acting oral drug15

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
16ZX008- Treatment for rare intractable epilepsy Development Phase

Japan: PIIIOrigin[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 based oncombination therapy.
17NS-580- Treatment for endometriosis Development Phase

Japan: PIIa

OriginNippon 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 potency18

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 form

InjectionFeature

・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.

19NS-229- Treatment for inflammatory diseases Development Phase

Japan: PIOrigin

Nippon Shinyaku

Development

Nippon Shinyaku

Mechanism of action

JAK1 inhibitor

Indication

Inflammatory diseases (to be determined)

Dosage form

TabletFeature

・Potent and highly selective JAK1 inhibitor
・High efficacy and good safety profiles are expected in thetreatment for inflammatory diseases20NS-917- Treatment for relapsed or refractory acute myeloid leukemia -Development Phase

Japan: Preparation for PI

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 continuous
infusion・Tolerable safety profile available to elderly patients with r/r
AML

21

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

Overseas (USA): PI/IIOrigin

Nippon 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.

22

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, 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.