Outline of Consolidated Financial Results
for the Year Ended March 31, 2022
May 13, 2022
NIPPON SHINYAKU CO., LTD.

FY2021 Summary◆ Net sales： 137,547 million yen （+12.8%）◆ Operating profit：

28,299 million yen （+ 8.3%）◆ Ordinary profit：

29,773 million yen （+11.3%）

Profit attributable：

23,044 million yen （+11.3%）◆ to owners of parent（Million yen）

Net Sales

Operating profit

Ordinary profit

Profit attributable toowners of parent

2

Segmental Review - Pharmaceuticals 106,478+4,811
Revenues from the licensing ofindustrial property rights＋8,869+491+14,171

120,650（Million yen）
Ethical drugs
Revenues from the licensing ofindustrial property rights

Profit in co-promotion
Net sales

FY2020YoY Change

FY2021Results

Ratio

Results

Ratio

Amt

%

73,69769.2%

78,50865.1%+4,811+6.5%

24,33822.9%

33,20727.5%+8,869+36.4%

8,442

7.9%

8,934

7.4%

+491

+5.8%

106,478

100.0%

120,650

100.0%+14,171+13.3%Net sales increased by 13.3% through growth of ethical drugs such as “Vidaza”, “Uptravi”,“Viltepso”, and revenues from the licensing of industrial property rights which contains of royalty
revenue from Uptravi’s overseas sales and gain on sales from the priority review voucher.
3

Segmental Review - Functional Food 15,406
+771
+190

-181
+709
+1,49016,897（Million yen）

FY2020

FY2021YoY Change

Results

Ratio

Results

Ratio

Amt

%

Protein preparations

10,121

65.7%

10,892

64.5%

+771

+7.6%

Preservatives

2,597

16.9%

2,787

16.5%

+190

+7.3%

Health food ingredients

1,257

8.2%

1,075

6.4%

-181

-14.4%

Others

1,431

9.2%

2,140

12.6%

+709

+49.6%Net sales

15,406100.0%

16,897100.0%+1,490+9.7%

Net sales increased by 9.7% through sales from functional food products
such as protein preparations, preservatives, etc.
4Operating profit
26,134+14,171+1,490-703-2,512-10,281+2,16428,299（Million yen）

FY2020

FY2021YoY Change

Results

Ratio

Results

Ratio

Amt

%

121,885

100.0%

137,547

100.0%+15,662+12.8%(Pharmaceuticals)(106,478)(87.4%)(120,650)(87.7%)(+14,171)(+13.3%)(Functional Food)(15,406)(12.6%)(16,897)(12.3%)(+1,490)(+9.7%)

Operating expenses

95,75078.6%

109,248

79.4%+13,497+14.1%

Cost of sales

49,95441.0%

50,657

36.8%

+703

+1.4%

SG&A expenses

29,691

24.4%

32,20423.4%+2,512+8.5%

R&D expenses

16,10413.2%

26,38619.2%+10,281+63.8%

Operating profit

26,13421.4%

28,29920.6%+2,164+8.3%

Net sales

5Profit attributable to owners of parent
20,702＋2,164+1,032-183-1,998＋1,372

23,044（Million yen）

FY2020

FY2021Results

Results＋2,431YoY Change
Amt%

Operating profit

26,13428,299+2,164+8.3%

Non-operating income

1,326

2,359

+1,032+77.8%

Non-operating expenses

701

884

+183

+26.2%

Ordinary profit

26,76029,773+3,013+11.3%

Extraordinary income

1,998

-

-1,998-

Income taxes, etc

8,056

6,729

-1,327-16.5%

20,702

23,044+2,341+11.3%

Profit attributableto owners of parent

6

Business Forecast for FY2022 (IFRS)FY2021

FY2022

Results*

Forecast

Revenue

137,484

Operating profit
Profit before tax（Million yen）

Profit attributableto owners of parent

YoY Change
Amt%134,000-3,484-2.5%

32,93627,000-5,936-18.0%

33,26627,500-5,766-17.3%

25,011

21,500-3,511-14.0%*Results for FY2021 are converted from JGAAP to IFRS(Converted results for FY2021 are unaudited provisional values)

In order to improve international comparability, the company will
voluntarily adopt International Financial Reporting Standards (IFRS)
starting with the consolidated financial statements in the annual
Securities Report for the year ended March 31, 2022.
7

Segmental Forecast - Pharmaceuticals (IFRS) -（Million yen）
Ethical drugs
Revenues from the licensing ofindustrial property rights
Profit in co-promotion
Revenue

FY2021Results*
Ratio

FY2022
Forecast
Ratio

YoY Change
Amt%

78,50865.1%

75,70065.8%-2,808-3.6%

33,20727.5%

29,80025.9%-3,407-10.3%

8,934

7.4%

9,500

8.3%

+566

+6.3%

120,650

100.0%

115,000

100.0%-5,650-4.7%*Results for FY2021 are converted from JGAAP to IFRS(Converted results for FY2021 are unaudited provisional values)

We look for sales of new products including “Viltepso” and “Upravi”,
revenues from the licensing of industrial property rights containing royalty
revenue from Uptravi’s overseas sales, and profit in co-promotion to grow.
However, due to price revision by MHLW, launch of generic drugs for“Vidaza”, and a backlash from the loss of sales revenue from the priority
review voucher booked in FY2021, we predict net sales to decline.
MHLW : Ministry of Health, Labour and Welfare8Segmental Forecast - Functional Food (IFRS) （Million yen）

FY2021Results*
Ratio

FY2022
Forecast
Ratio

YoY Change
Amt%

Protein preparations

10,87064.6%

13,00068.4%+2,130+19.6%

Preservatives

2,788

16.6%

2,900

15.3%

+112

+4.0%

Health food ingredients

1,078

6.4%

1,100

5.8%

+22

+2.0%

Others

2,096

12.4%

2,000

10.5%

-96

-4.6%

Revenue

16,834100.0%

19,000100.0%+2,166+12.9%*Results for FY2021 are converted from JGAAP to IFRS(Converted results for FY2021 are unaudited provisional values)

We will enhance our research and development toward new products
and continue to launch highly valued products with market needs toincrease our revenue.

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

FY2021

FY2022YoY Change

Results*

Ratio

Forecast

Ratio

Amt

%

137,484

100.0%

134,000

100.0%-3,484-2.5%(Pharmaceuticals)(120,650)(87.8%)(115,000)(85.8%)(-5,650)(-4.7%)(Functional Food)(16,834)(12.2%)(19,000)(14.2%)(+2,166)(+12.9%)

Cost of sales

50,18836.5%

51,000

38.1%

+812

+1.6%

SG&A expenses

32,19523.4%

31,900

23.8%

-295

-0.9%

R&D expenses

22,87016.6%

24,40018.2%+1,530+6.7%

Other income

1,578

1.1%

800

0.6%

-778

-49.3%

Other expenses

872

0.6%

500

0.4%

-372

-42.7%

Operating profit

32,93624.0%

27,00020.1%-5,936-18.0%

Finance income

472

0.3%

500

0.4%

+28

+5.8%

Finance costs

142

0.1%

-

-

-142

-

Profit before tax

33,26624.2%

27,50020.5%-5,766-17.3%

Income tax expense, etc

8,254

6.0%

6,000

4.5%

-2,254-27.3%

25,011

18.2%

21,50016.0%-3,511-14.0%

Revenue

Profit attributableto owners of parent*Results for FY2021 are converted from JGAAP to IFRS(Converted results for FY2021 are unaudited provisional values)

10Dividends Forecast
FY2021

FY2022

Interim¥51¥56

Annual¥110¥112¥342.14¥319.2132.2 ％

35.1 ％

Dividends per share

Net income per share /Basic earnings per share
Payout ratio (consolidated)*Year-end dividend for FY 2021 is raised from 52 yen to 59 yen*Basic earnings per share and payout ratio (consolidated) is calculated based on
International Financial Reporting Standards (IFRS)

110

(Yen)

112

99
86
Annual70

Interim11(estimated)

R&D Pipeline

R&D Pipeline (Domestic) ①
Code No.
(Generic name)<Origin>Application
type

Indications

Preparation
for PI/IIPI

NS-065/NCNP-01(viltolarsen)

PI

NME

Duchenne muscular dystrophy

NME

Iron deficiency anemia

NME

Dravet syndrome

NME

Lennox-Gastaut syndrome<in-house>

PII

Preparation

PIII

for PIII

NDA

Preparation

Launchfor launch

PII

PIII
in progress

NS-32(ferric
derisomaltose)<in-license>
ZX008(fenfluraminehydrochloride)<in-license>
ZX008(fenfluraminehydrochloride)<in-license>
GA101（obinutuzumab）<in-license>

New
indication

Lupus nephritis： Changes from 3rd Quarter FY2021

13

R&D Pipeline (Domestic) ②
Code No.
(Generic name)<Origin>Application
type

Indications

PI

Preparation
for PI/II

PII

Preparation
for PIII

PIII

NDA

Preparation

Launchfor launch

PIII

New
NS-304indication

Arteriosclerosis obliterans(selexipag)<in-house>
New dose

NS-580<in-house>
NS-87（daunorubicin /cytarabine）<in-license>

NME

New
combination

NS-401(tagraxofusp)

NME<in-license>

NS-229<in-house>

NME

NS-917(radgocitabine)<in-license>

NME

Pediatric pulmonary arterial
hypertension

Endometriosis

Secondary acute myeloid
leukemia

Blastic plasmacytoid dendritic
cell neoplasm

Inflammatory diseases

Relapsed/refractory acute
myeloid leukemia： Changes from 3rd Quarter FY2021

14

R&D Pipeline (Overseas)
Code No.
(Generic name)<Origin>Application
type

Indications

NS-065/NCNP-01(viltolarsen)

NME

Duchenne muscular dystrophy

NME

Duchenne muscular dystrophy

NME

Myelofibrosis<in-house>

CAP-1002<partnership>PI

Preparation
for PⅡ

PII

Preparation
for PIIIPIII

LaunchPIIIin progress

NS-018(ilginatinib)<in-house>

15Reference Materials

Consolidated Statements of Income(Million yen）

FY2020

FY2021

YoY change

Results

Ratio

Results

Ratio

Amt

%

121,885

100.0%

137,547

100.0%+15,662+12.8%(Pharmaceuticals)(106,478)(87.4%)(120,650)(87.7%)(+14,171)(+13.3%)(Functional Food)(15,406)(12.6%)(16,897)(12.3%)(+1,490)(+9.7%)

Cost of sales

49,95441.0%

50,657

36.8%

+703

+1.4%

SG&A expenses

29,691

24.4%

32,20423.4%+2,512+8.5%

R&D expenses

16,10413.2%

26,38619.2%+10,281+63.8%

Operating profit

26,13421.4%

28,29920.6%+2,164+8.3%

Non-operating income

1,326

1.1%

2,359

1.7%

+1,032+77.8%

Non-operating expenses

701

0.5%

884

0.7%

+183

+26.2%

Ordinary profit

26,76022.0%

29,77321.6%+3,013+11.3%

Extraordinary income

1,998

1.6%

-

-

-1,998-

Income taxes, etc

8,056

6.6%

6,729

4.9%

-1,327-16.5%

20,70217.0%

23,04416.8%+2,341+11.3%Net sales

Profit attributableto owners of parent

17

Consolidated Balance Sheet
End of

End ofYoY Change

End of

End ofYoY Change

FY2020

FY2021Amt

FY2020

FY2021

Amt（Million yen）

Assets197,028

210,052+13,024

Current assets

139,090

149,632+10,542

Fixed assets

57,93760,419+2,482

Liabilities

34,48533,285-1,199Current liabilities

31,51429,288-2,225Long-term liabilities

2,970

3,997

+1,026

162,543

176,767+14,223

197,028

210,052+13,024

Net assets
Total assets

197,028

210,052+13,024

Total liabilities
and net assets＝Liabilities and Net assets＝＝Assets＝Cash and deposits+2,643

Accounts payable+2,956

Notes and accounts receivable+2,839

Income taxes payable-3,497

Inventories+2,329Accrued consumption taxes-381

000 ＋2,574

Net defined benefit liability+1,033

Property, plant and equipment0
Deferred tax asset＋1,305Retained earnings＋16,24118

Consolidated Statements of Cash Flows（Million yen）

FY2020

FY2021YoY Change

Results

Results

Amt

Operating activities

21,38816,018-5,369Investing activities-1,564-6,359-4,795

Financing activities-6,199-6,801-602

57,88360,566+2,683

Cash and cash equivalents
at end of period

FY2021

FY2020+ 16,018+21,388- 1,564- 6,359- 6,801- 6,199
57,88360,56644,29819

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

・Japan : Launch・USA : Launch・Global : PIII in progress

OriginCo-development :National Center of Neurology and Psychiatry

Development

Nippon Shinyaku

Mechanism ofactionExon 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 highsafety profile and maximized activity

20NS-32 (ferric derisomaltose)- Treatment for iron deficiency anemia Development Phase

Japan : Preparation for launch

Origin[Dec. 2016]
Licensed-in from : Pharmacosmos A/SDevelopment

Nippon Shinyaku

Mechanism of action

Iron

Indication

Iron deficiency anemia

Dosage form

IV bolus injection or IV drip infusion

Feature・Can be administered in high doses allowing full ironcorrection in the majority of patients・Good safety profile with no dose dependent ADRs
・Minimal potential toxicity from release of labile iron due
to tight iron binding in a matrix structure of interchanging
isomaltoside and iron・No profound hypophosphatemia
21

ZX008 (fenfluramine hydrochloride)- Treatment for rare intractable epilepsy Development Phase

Japan : NDA filing (Dravet syndrome)
Japan : PⅢ （Lennox-Gastaut syndrome)

Origin[Mar. 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-Gastautsyndrome patients refractory to existing treatment
options・ZX008 can be used in combination with other drugs, asstandard of care for intractable epilepsy based on
combination therapy
22

CAP-1002- Treatment for Duchenne muscular dystrophy Development Phase

USA : Preparation for PIII

Origin[Jan. 2022]
Partnership for commercialization :Capricor Therapeutics, Inc.

Development

Capricor Therapeutics, Inc.

Mechanism ofactionExosomes released from cardiosphere-derived cells

Indication

Duchenne muscular dystrophy

Dosage form

Injection

Feature・Exosomes released from this drug are expected to reduce
oxidative stress, inflammation, fibrosis, and increase cell
energy and myocyte generation, resulting in improvementof motor and cardiac functions
・Its broad applicability makes it suitable for patients
regardless of the type of genetic mutation
23

GA101 (Obinutuzumab)- Treatment for lupus nephritis Development Phase

Japan : Preparation for PIII

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

Development

Co-development : Chugai Pharmaceutical Co., Ltd.

Mechanism ofactionAnti-CD20 monoclonal antibody

Indication

Lupus nephritis

Dosage form

Injection

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

24

NS-304 (selexipag)
for pulmonary
hypertension,-- Treatment
Treatment
for Luhritis- arteriosclerosis obliterans Development Phase

Japan : PIIb（ASO）
Japan : PII （Pediatric PAH）

OriginNippon Shinyaku

Development

・Nippon Shinyaku（ASO）
・Co-development :Janssen Pharmaceutical K.K. (Pediatric PAH)

Mechanism of action

Selective IP receptor agonist

Indication

・Arteriosclerosis obliterans (ASO)
・Pediatric pulmonary arterial hypertension (Pediatric
PAH)

Dosage form

TabletFeatureLong-acting oral drug25

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 andwith possible analgesic potency26

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

USA : Preparation for PII

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 isavailable27NS-87 (daunorubicin / cytarabine)- Treatment for secondary acute myeloid leukemia Development Phase

Japan : PI/II

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

Development

Nippon Shinyaku

Mechanism of action

Liposomal combination of daunorubicin and cytarabine

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 inbone marrow28

NS-401 (tagraxofusp)- Treatment for blastic plasmacytoid dendritic cell neoplasm Development Phase

Japan : Preparation for PI/II

Origin[Mar. 2021]
Licensed-in from: The Menarini Group

Development

Nippon Shinyaku

Mechanism of action

Induction apoptosis of cells by inhibiting protein synthesisby specifically targeting cancer cells expressing CD123

Indication

Blastic plasmacytoid dendritic cell neoplasm (BPDCN)

Dosage form

Injection

Feature・Composed of diphtheria toxin (DT) fusion protein andrecombinant human IL-3
・Novel targeted therapy directed to CD123 on tumor cells
・IL-3 binds to CD123-expressing tumor cells and delivers
the cytotoxic diphtheria toxin to the cells, resulting in
the blockage of protein synthesis in the cell and causing
cell death in CD123-expressing cells
29NS-229- Treatment for inflammatory diseases Development Phase

Japan : PI

OriginNippon Shinyaku

Development

Nippon Shinyaku

Mechanism of action

JAK1 inhibitor

Indication

Inflammatory diseases (to be determined)

Dosage form

Oral agent

Feature・Potent and highly selective JAK1 inhibitor
・High efficacy and good safety profiles are expected in
the treatment for inflammatory diseases30

NS-917 (radgocitabine)- Treatment for relapsed or refractory acute myeloid leukemia Development Phase

Japan : PI

Origin[Mar. 2017]
Licensed-in from : Delta-Fly Pharma, Inc.

Development

Nippon Shinyaku

Mechanism of action

DNA strand-break by incorporating itself into DNA

Indication

Relapsed or refractory (r/r) acute myeloid leukemia (AML)

Dosage form

Injection

Feature・Significant anti-leukemic activity with uniquemechanism of action from other nucleoside analogs at
low dose continuous infusion
・Tolerable safety profile available to elderly patients with
r/r AML31

Safe Harbor Statement• Materials and information provided during this presentation may contain so-called “forward-looking
statements.” 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 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.

appendix

Nippon Shinyaku Co., Ltd.
Financial Results Briefing for the Fiscal Year Ended March 2022
May 13, 2022

appendix

Nakai: I am Toru Nakai, President of Nippon Shinyaku.
Thank you very much for participating in our financial results briefing for FY2021 today. I appreciate it verymuch.
Today, I would like to report on our business performance for FY2021 and our full-year business forecast for
FY2022, and Mr. Takagaki will explain you the progress of our R&D items.

For our financial results for FY2022, consolidated net sales were JPY137.547 billion, operating profit was
JPY28.299 billion, ordinary income was JPY29.773 billion, and net profit was JPY23.044 billion.

1

appendix

In the Pharmaceuticals business, sales of Vidaza, a treatment for myelodysplastic syndrome and acute myeloid
leukemia, Uptravi, a treatment for pulmonary arterial hypertension and chronic thromboembolic pulmonary
hypertension, and Viltepso, a treatment for Duchenne muscular dystrophy, grew.
In addition, royalty income from overseas sales of Uptravi and revenues from the sale of priority review
voucher contributed to consolidated net sales of the pharmaceutical business of JPY120,650 million, up by
13.3% YoY.

2

appendix

In the Functional Food business, consolidated net sales increased by 9.7% YoY to JPY16,897 million due toincreased sales of protein preparations and preservatives.

3appendix

Next, as for operating expenses, the cost of sales ratio improved by 4.2 percentage points YoY to 36.8%, due
to factors such as the sales mix, which include an increase in revenues from the licensing of industrial property
rights.
SG&A expenses increased to JPY32,204 million, up by 8.5% YoY, from the increase of sales activities that had
been restrained due to COVID-19, sales promotion fees associated with increased domestic sales of Uptravi,
and expenses associated with strengthening sales in the functional food business.
R&D expenses totaled JPY26,386 million, up by 63.8% YoY, due to an increase in manufacturing costs forinvestigational nucleic acid drugs in line with progress in clinical trials, as well as upfront payments for DYN101
for which an option agreement was concluded last November and CAP-1002 for which a commercializationand distribution agreement in the US was concluded in January this year.
As a result, operating profit was JPY28,299 million, up by 8.3% YoY.

4

appendix

Ordinary profit was JPY29,773 million, up by 11.3% YoY, and net profit was JPY23,044 million, up by 11.3%
YoY.

5

appendix

I will now explain our full-year business forecast for FY2022.
Since the percentage of foreign investors in our shareholder composition continues to be high, we havedecided to adopt International Financial Reporting Standards on a voluntary basis beginning with theconsolidated financial statements in the Annual Securities Report for the fiscal year ending March 31, 2022,
in order to improve the international comparability of our financial information.
Based on this, for the full year of FY2022, we forecast consolidated net sales of JPY134 billion, andconsolidated profit of JPY27 billion for operating profit, JPY27.5 billion for profit before tax, and JPY21.5 billion
for profit attributable to owners of parent.

6appendix

In the Pharmaceutical business, we forecast net sales of JPY115 billion, a YoY decrease of 4.7%.
In addition to growth of new products such as Viltepso and Uptravi, revenues from the licensing of industrial
property rights which include of royalty revenue from overseas sales of Uptravi, and profit in co-promotion
are expected to grow. However, due to the drug price revision by MHLW, launch of generic drugs for Vidaza
and the loss of sales revenue of the priority review voucher in the previous fiscal year, sales are expected todecrease.

7

appendix

The Functional Food business is expected to post sales of JPY19 billion, a YoY increase of 12.9%. We expect anincrease in sales by further focusing on new product development and strengthening our efforts in priority
products.

8appendix

Next, regarding operating expenses, the cost to sales ratio is expected to be 38.1%, a deterioration of 1.6
percentage points YoY.
SG&A expenses are expected to be JPY31.9 billion, and R&D expenses is expected to be JPY24.4 billion.
As a result, operating profit is expected to be JPY27 billion, profit before tax JPY27.5 billion, and profit
attributable to owners of parent JPY21.5 billion.

9

appendix

As for dividends, we plan to pay dividends with a consolidated payout ratio of around 35% as a performancelinked dividend for the period of the Sixth Mid-Term Management Plan.
In accordance with this dividend policy, we plan to pay an interim dividend of JPY56 per share and a year-end
dividend of JPY56 per share, for an annual dividend of JPY112 per share.
The Company also plans to increase the year-end dividend for the previous fiscal year from JPY52 to JPY59,
raising the annual dividend from JPY103 to JPY110.
This concludes my presentation for the financial results for FY2021 and the forecast for FY2022.

10

appendix

Takagaki: I will continue with the progress of R&D items.
First, I would like to explain the development situation in Japan.
NS-065/NCNP-01, a treatment for Duchenne muscular dystrophy, was approved in March 2020 and launchedin May 2020. A global Phase III study is currently underway.
In March this year, we obtained manufacturing and marketing approval for NS-32, an iron deficiency anemia
treatment, and are currently preparing for its launch.
For ZX008, a drug for the treatment of intractable epilepsy, which we have in-licensed from Zogenix, Inc., hasbeen submitted for approval in December 2021 for the treatment of Dravet syndrome by the company.
In addition, a Phase III study for Lennox-Gastaut syndrome is underway by the in-licensed company, Zogenix,
Inc.
A Phase III study of GA101 for lupus nephritis is under preparation in collaboration with Chugai PharmaceuticalCo.

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In February of this year, Nippon Shinyaku independently initiated a Phase IIb study of NS-304 for the indicationof arteriosclerosis obliterans. In addition, a Phase II study for pediatric pulmonary arterial hypertension isunderway in collaboration with Janssen Pharmaceutical K.K.
Phase IIa study is underway for NS-580, an endometriosis treatment.
A Phase I/II study of NS-87, a treatment for secondary acute myeloid leukemia, is underway.
A Phase I/II study of NS-401 for the treatment of blastic plasmacytoid dendritic cell neoplasm is in preparation.
A Phase I study of the JAK1 inhibitor NS-229 is underway for the treatment of inflammatory diseases.
In February of this year, we started Phase I trials for NS-917 for the treatment of relapsed/refractory acute
myeloid leukemia.

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Next, I will explain the status of overseas development.
The Duchenne muscular dystrophy treatment NS-065/NCNP-01 was approved and launched in the US in
August 2020. A global Phase III study is currently underway.
It was also designated as an orphan drug in Europe in June 2020.
In China, we submitted an application for approval in June 2021, but in consultation with the Chinese
authorities, the application was temporarily withdrawn because they recommended resubmitting theapplication with the results of the global Phase III study due to the small number of cases in Japan and the US
as the product was approved through the early approval system.
As of Europe, we plan to submit another application for approval based on the results of the global Phase III
study.
In January of this year, we entered into an exclusive partnership for commercialization and distribution of
CAP-1002 for the treatment of Duchenne musucular dystrophy in the US with Capricor Therapeutics.
Capricor Therapeutics is currently preparing for Phase III trials in the US.
We are currently preparing for the following study in the US for NS-018, a drug for myelofibrosis.
This concludes the overview of our R&D activities.

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