Outline of Consolidated Financial Results for the First Quarter Ended June 30, 2022(IFRS)
August 9, 2022
Name of the listed company: NIPPON SHINYAKU CO., LTD.
Listing stock exchange: Tokyo
Code No.: 4516
URL https://www.nippon-shinyaku.co.jp/
Representative: Toru Nakai, President and Representative Director
Contact: Hideyuki Fujii, Department Manager and Finance & Accounting Dept.
Tel. +81-75-321-9116
Scheduled date for submission of quarterly Securities Report: August 12, 2022
Scheduled start of payment: －Supplementary material:
Yes
Financial result meeting:Yes (for institutional investors and securities analysts on conference call)* All amounts are rounded down to the nearest million yen.
1. Consolidated Results for the Year Ended June 30, 2022 (April 1, 2022 to June 30, 2022)(1) Operating results%
35,619 (13.1)%
10,276 (37.9)%
10,514 (37.3)(¥ million)
Profit attributable
ComprehensiveProfitto owners ofincome
parent%%%8,253 (34.5)
8,249 (34.5)
8,315 (27.1)

40,96816,55916,77012,594

RevenueThree months ended
June 30, 2022
Three months ended
June 30, 2021

Operating profit Profit before tax－－－－

12,589－11,412－

Earnings per share (¥)
Basic
DilutedThree months ended－
June 30, 2022
122.48Three months ended－
June 30, 2021
186.91
Note: Equity-method investments: not applicable(2) Financial position(¥ million)
Ratio of equity attributable
Total equity attributable toTotal equity
to owners of parent to total
owners of parent
assets185,227
184,92284.2%
180,886
180,585
82.1%

Total assets
As of June 30, 2022
As of March 31, 2022

219,684
219,943

2. Dividends
Annual dividends per share (¥)
st1 quarter
Year ended March 31, 2022
Year ending March 31, 2023
Year ending
March 31, 2023 (forecast)nd2 quarter－－rdYear-end

3 quarter

Annual51.00－59.00110.0056.00－56.00112.003. Business Forecast for the Year Ending March 31, 2023 (April 1, 2022 to March 31, 2023)(¥ million)
RevenueFirst-half period
Full term

67,000134,000

Operating profit%－(2.5)

14,50027,000%－(18.1)-1-

Profit before tax

14,70027,500%－(17.4)

Net income
Basic earnings perattributable toshare (¥)
owners of the parent
11,30021,500%－(14.0)167.77319.21

4. Others(1) Changes in the scope of consolidation
Inclusion: None
Exclusion: None
Note: Changes in specified subsidiaries involved changes in the scope of consolidation(2) Changes in accounting policies and accounting estimates, and restatement
1. Changes in accounting policies arising from revision of accounting standards: None
2. Changes in arising from other factors: None
3. Changes in accounting estimates: None
(3) Number of shares outstanding (ordinary shares)
Number of shares outstanding (including treasury stock)
As of June 30, 2022:
70,251,484 shares
As of March 31, 2022:
Number of shares of treasury stock
As of June 30, 2022:
As of March 31, 2022:

70,251,484 shares
2,898,500 shares
2,898,434 shares

Average number of shares outstanding (total for the consolidated period)
As of June 30, 2022:
67,353,034 shares
As of June 30, 2021:

67,353,291 shares

Note:
This summary of quarterly financial results is exempt from the quarterly review procedures under the Financial Instruments andExchange Act. At the time of disclosure, published figures in this financial release have not been completed to a quarterly review offinancial statements based on the Financial Instruments and Exchange Law.
This financial release contains certain statements about the future, which are based information available and deemed reasonable toNippon Shinyaku at the time of announcement, and are not the commitments made by Nippon Shinyaku.
Readers are advised that actual results may differ substantially from the above forecasts due to various unforeseeable factors.

-2-5. Consolidated Financial Statement(1) Consolidated Balance Sheet(Millions of yen)
As of March 31,2022
AssetsCurrent assets
Cash and cash equivalents
Trade and other receivables
Inventories
Other financial assets
Other current assets
Total current assets
Non-current assets
Property, plant and equipment
Intangible assets
Right-of-use assets
Other financial assets
Deferred tax assets
Other non-current assets
Total non-current assets
Total assets-3-

As of June 30, 2022

60,56643,17838,066
5,174
2,738
149,724

58,91545,72436,662
4,530
3,452
149,284

28,304
14,0502,753
22,294901
1,915
70,219219,943

28,541
13,5252,760
22,768934
1,867
70,399219,684

(Millions of yen)
As of March 31,2022
Liabilities and equity
Liabilities
Current liabilities
Trade and other payables
Other financial liabilities
Lease liabilities
Income taxes payable
Other current liabilities
Total current liabilities
Non-current liabilities
Other financial liabilities
Lease liabilities
Retirement benefit liability
Other non-current liabilities
Total non-current liabilities
Total liabilities
EquityShare capital
Capital surplus
Retained earnings
Treasury shares
Other components of equity
Total equity attributable to owners of parent
Non-controlling interests
Total equity
Total liabilities and equity-4-

As of June 30, 2022

21,022
374
1,494
3,123
6,014
32,02915,200
398
1,395
2,106
8,516
27,616

237
1,219
5,506
64
7,027
39,057

232
1,200
5,338
67
6,839
34,456

5,174
4,445
165,303(2,478)8,140
180,585300
180,886
219,943

5,174
4,445
169,579(2,479)8,202
184,922305
185,227
219,684

(2) Consolidated Statements of Income(Millions of yen)Three months ended
June 30, 2021

Three months ended
June 30, 2022

Revenue
Cost of sales
Gross profit
Selling, general and administrative expenses
Research and development expenses
Other income
Other expenses
Operating profit
Finance income
Finance costs
Profit before tax
Income tax expense
Profit40,96812,89828,069
7,681
3,737
135
226
16,559234
2316,7704,175
12,59435,61913,92821,690
8,200
4,738
1,652
128
10,276266
28
10,5142,260
8,253

Profit attributable toOwners of parent
Non-controlling interests
Profit12,589512,594

8,249
48,253

Earnings per shareBasic earnings per share

186.91

122.48-5-

(Consolidated Statements of Comprehensive Income)(Millions of yen)Three months ended
June 30, 2021
ProfitOther comprehensive income
Items that will not be reclassified to profit
or loss
Financial assets measured at fair value
through other comprehensive income
Total of items that will not be reclassified
to profit or loss
Items that may be reclassified to profit or loss
Exchange differences on translation offoreign operations
Total of items that may be reclassified toprofit or loss
Total other comprehensive income
Comprehensive incomeComprehensive income attributable toOwners of parent
Non-controlling interests
Comprehensive income-6-Three months ended
June 30, 2022

12,594

8,253(1,206)319(1,206)319

24(258)24(258)(1,182)
11,412

61
8,315

11,407
5
11,412

8,310
4
8,315

(3) Consolidated Statements of Changes in Net Assets
For the three-month period ended June 30,2021(Millions of yen)
Equity attributable to owners of parent

Balance at beginning of period
ProfitOther comprehensive income
Comprehensive income
Purchase of treasury shares
Dividends of surplus
Total transactions with owners
Balance at end of period

SharecapitalCapitalsurplusRetainedearnings

Treasuryshares

5,174
5,174

4,445
4,445

146,796
12,58912,589(3,367)(3,367)156,017(2,476)(0)(0)(2,476)

Noncontrollinginterests

Total

Equity attributable toowners of parent
Othercomponentsof equity
Total

Total
Balance at beginning of period
ProfitOther comprehensive income
Comprehensive income
Purchase of treasury shares
Dividends of surplus
Total transactions with owners
Balance at end of period

9,221(1,182)(1,182)
8,039

163,161
12,589(1,182)
11,407(0)(3,367)(3,367)
171,200

-7-

288
55293

163,449
12,594(1,182)
11,412(0)(3,367)(3,367)
171,494

Other components ofequity
Financial
Exchange
assetsdifference measured
s on
at fairtranslatio
valuethrough
n offoreignotheroperations comprehens
ive income
(93)
9,315
24(1,206)
24(1,206)
(68)
8,108

For the three-month period ended June 30,2022(Millions of yen)
Equity attributable to owners of parent

Balance at beginning of period
ProfitOther comprehensive income
Comprehensive income
Purchase of treasury shares
Dividends of surplus
Total transactions with owners
Balance at end of period

SharecapitalCapitalsurplusRetainedearnings

Treasuryshares

5,174
5,174

4,445
4,445

165,303
8,249
8,249(3,973)(3,973)
169,579(2,478)(0)(0)(2,479)Noncontrollin
ginterests

Total

Equity attributable toowners of parent
Othercomponentsof equity
Total

Total
Balance at beginning of period
ProfitOther comprehensive income
Comprehensive income
Purchase of treasury shares
Dividends of surplus
Total transactions with owners
Balance at end of period

8,1406161
8,202

180,5858,249
61
8,310(0)(3,973)(3,974)
184,922

-8-

300
4
4305

180,886
8,253
61
8,315(0)(3,973)(3,974)
185,227

Other components ofequity
Financial
Exchange
assetsdifference measured
s on
at fairtranslatio
valuethroughn offoreignotheroperations comprehens
ive income(253)
8,394(258)319(258)319(512)8,714

(4) Consolidated Statements of Cash Flows
Three months ended
June 30, 2021
Cash flows from operating activities
Profit before tax
Depreciation and amortization
Interest and dividend income
Interest expenses
Foreign exchange loss (gain)
Loss (gain) on sale of fixed assets
Decrease (increase) in trade and otherreceivables
Decrease (increase) in inventories
Increase (decrease) in trade and otherpayables
Increase (decrease) in retirement benefit
liability
Other
SubtotalInterest and dividends received
Interest paid
Income taxes paid
Net cash provided by (used in) operating
activities
Cash flows from investing activities
Payments into time deposits
Proceeds from withdrawal of time deposits
Purchase of property, plant and equipment
Purchase of intangible assets
Purchase of investments
Proceeds from sale and redemption ofinvestments
OtherNet cash provided by (used in) investing
activities
Cash flows from financing activities
Repayments of lease liabilities
Purchase of treasury shares
Dividends paid
Net cash provided by (used in) financing
activities
Effect of exchange rate changes on cash and cash
equivalents
Net increase (decrease) in cash and cash
equivalents
Cash and cash equivalents at beginning of period
Cash and cash equivalents at end of period-9-

Three months ended
June 30, 2022

16,7701,119(234)140
1110,514
1,221(266)
15(720)15(1,839)(2,392)

(198)

1,508

(1,738)(4,750)

(164)

(175)

177
13,917234(7)(6,746)

2,096
7,065
266
(8)
(3,451)

7,397

3,872

(45)
30(551)(1,670)
(0)

(45)
30
(860)
(1,243)(1,850)

－

2,400

2

1

(2,234)(1,566)(396)(0)(3,161)(535)(0)(3,753)(3,557)(4,289)

25

331

1,630

(1,651)

57,88359,51360,566
58,915

Appendix ：Ｌｅａｄｉｎｇ Ｐｒｏｄｕｃｔｓ

Performance (consolidated)

Revenue
Operating profit
Profit before tax
Profit attributable toowners of parent(¥ million)
2022(IFRS)(estimated)

2016(JGAAP)2017(JGAAP)2018(JGAAP)2019(JGAAP)2020(IFRS)

2021(IFRS)

98,781

101,448

114,716

116,637

121,859

137,484

134,000

15,28017,07920,644

21,66827,702

32,94827,000

16,244

17,451

21,54022,442

27,60833,301

27,50011,74912,953

16,302

16,866

19,54024,986

21,500(¥ million)
Brand nameVidazaActive Ingredientazacitidine

Indications

Launch Date

Sales 2020
(IFRS)

Sales 2021
(IFRS)

Apr-JunApr-Sep(estimated)

Annual(estimated)myelodysplastic
syndrome/
acute myeloid leukemia

Mar-2011/
Mar-2021

15,35018,338

4,800

7,800

12,400

2,387

7,750

3,193

5,900

13,000(1,953)(4,059)(1,054)(2,200)(4,750)(434)(3,691)(2,139)(3,700)(8,250)Viltepso(Japan)viltolarsen

Sales 2022 (IFRS)

Duchenne muscular
dystrophy

Japan May-2020
U.S. Aug-2020(U.S.)

Uptraviselexipag

pulmonary arterial
hypertension/
chronic thromboembolic
pulmonary hypertension

Nov-2016/
Aug-2021

6,804

8,400

2,367

4,500

9,800

Tramal, Onetram

tramadolhydrochloride

cancer pain, chronic pain

Sep-2010

6,906

6,770

1,674

2,700

5,000

Gazyvaobinutuzumab

CD20-positive follicularlymphomaAug-2018

5,312

5,300

1,333

2,700

5,800

Zalutiatadalafil

urinary disorder causedby benign prostatic
hyperplasia

Apr-2014

6,743

4,106

771

1,300

2,300

Cialistadalafil

erectile dysfunction

Jul-2009

2,677

2,532

754

1,250

2,600

Adcircatadalafil

pulmonary arterial
hypertension

Dec-2009

5,474

4,563

742

1,400

2,500

Defitelio

defibrotide sodium

sinusoidal obstruction
syndrome

Sep-2019

1,970

2,128

594

1,000

2,300Erizas

dexamethasone
cipecilate

allergic rhinitis

Dec-2009

2,444

2,330

385

700

2,400

Profit in co-promotion

8,442

8,934

2,603

4,600

9,500

Revenues from the licensing of industrial property rights

24,33833,207

6,903

14,60029,800

Pharmaceuticals

106,478

120,650

30,40757,400115,000

Functional Food

15,38016,834

5,211

9,600

19,000

Revenue

121,859

137,484

35,61967,000134,000-10-Appendix ：Ｒ＆Ｄ Pipeline List
As of August 9. 2022

＜Domestic＞
Code No.
(Generic name)

Therapeutic field

LaunchPhase III

NS-065/NCNP-01(viltolarsen)

intractable disease ・orphan disease

Duchenne muscular
dystrophy

Co - development:
National Center of Neurology andPsychiatry

Nippon Shinyaku

Preparation forlaunch

NS-32(ferricderisomaltose)

gynecology

iron deficiency anemia

Licensed - in fromPharmacosmos A/S

Nippon Shinyaku

NDA filing

ZX008(fenfluraminehydrochloride)

intractable disease ・orphan disease

Dravet syndrome

Licensed - in from UCB S.A.
(former : Zogenix, Inc.)UCB S.A.
(former : Zogenix, Inc.)

Phase III

ZX008
(fenfluraminehydrochloride)

intractable disease ・orphan disease

Lennox-Gastautsyndrome

Licensed - in from UCB S.A.
(former : Zogenix, Inc.)UCB S.A.
(former : Zogenix, Inc.)

Phase IIIGA101
(obinutuzumab)

inflammatory
diseaseslupus nephritis

Licensed - in from
Chugai Pharmaceutical Co., Ltd.

Co - development:
Chugai Pharmaceutical Co., Ltd.

Phase II

NS-304(selexipag)

cardiovasculararteriosclerosis
obliterans

Nippon Shinyaku

Nippon Shinyaku

Phase II

NS-304(selexipag)

intractable disease ・orphan disease

pediatric pulmonary
arterial hypertension

Nippon Shinyaku

Co - development:
Janssen Pharmaceutical K.K.

Phase II

NS-580gynecology

endometriosis

Nippon Shinyaku

Nippon Shinyaku

Phase I/II

NS-87
(daunorubicin/cytarabine)

hematologic
malignancies

secondary acute
myeloid leukemia

Licensed - in from
Jazz Pharmaceuticals plc

Nippon Shinyaku

Phase I/II

NS-401(tagraxofusp)

hematologic
malignancies

blastic plasmacytoid
Licensed - in fromdendritic cell neoplasm The Menarini Group

Nippon Shinyaku

Phase I

NS-229inflammatory
diseases

inflammatory diseases Nippon Shinyaku

Nippon Shinyaku

Phase I

NS-917(radgocitabine)

hematologic
malignancies

relapsed/refractory
Licensed - in fromacute myeloid leukemia Delta-Fly Pharma, Inc.

Nippon Shinyaku

StageIndications

OriginDevelopment＜Overseas＞
Stage

Code No.
(Generic name)

Therapeutic field

U.S. Launch
Phase III

NS-065/NCNP-01(viltolarsen)

intractable disease・orphan disease

Duchenne muscular
dystrophy

Co - development:
National Center of Neurology andPsychiatry

Nippon Shinyaku

Phase IIICAP-1002

intractable disease・orphan disease

Duchenne muscular
dystrophy

Partnership:
Capricor Therapeutics, Inc.

Capricor Therapeutics, Inc.

Preparation forPhase II

NS-018(ilginatinib)

hematologic
malignanciesmyelofibrosis

Nippon Shinyaku

Nippon Shinyaku

Indications-11-

OriginDevelopment