Outline of Consolidated Financial Results for the Second Quarter Ended September 30, 2022
(IFRS)
November 10, 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: November 14, 2022
Scheduled start of payment: December 5, 2022
Supplementary material:YesFinancial 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 September 30, 2022 (April 1, 2022 to September 30, 2022)(1) Operating results(¥ million)
Profit attributable
Comprehensive
Revenue
Operating profit Profit before tax
Profitto owners ofincomeparent
Second quarter ended%%%%%%
September 30, 2022
71,136 (0.6) 19,161 (12.1) 19,398 (11.9) 15,228 (7.9) 15,222 (7.9) 14,591 (7.9)
Second quarter ended
September 30, 2021
71,533
16,519－ 21,808－ 22,006－ 16,527－－ 15,837－
Earnings per share (¥)
Basic
DilutedSecond quarter ended
September 30, 2022
226.01－
Second quarter ended
September 30, 2021
245.27－
Note: Equity-method investments: not applicable(2) Financial position(¥ million)
Ratio of equity
Total equity attributable toTotal equity
attributable to owners ofowners of parent
parent to total assets
191,503
191,19784.8%
180,886
180,585
82.1%

Total assets
As of September 30, 2022
As of March 31, 2022225,374
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

rd

51.00
57.00

－－

Year-end

3 quarter

Annual－59.00

110.00－57.00

114.003. Business Forecast for the Year Ending March 31, 2023 (April 1, 2022 to March 31, 2023)(¥ million)
Revenue

Full term

141,000

Operating profit%
2.6

30,000%(8.9)-1-Profit before tax

30,400%(8.7)

Profit attributable
Basic earnings perto owners ofshare (¥)
parentt
24,000%(4.0)

356.33

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 September 30, 2022:70,251,484 shares
As of March 31, 2022:

70,251,484 shares

Number of shares of treasury stock
As of September 30, 2022:
As of March 31, 2022:

2,898,520 shares
2,898,434 shares

Average number of shares outstanding (total for the consolidated period)
As of September 30, 2022:
67,353,007 shares
As of September 30, 2021:

67,353,287 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 31,2022Assets
Current 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 September 30, 2022

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

63,44944,61436,3496,435
4,490
155,339

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

30,07012,7272,516
21,929904
1,886
70,035
225,374(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 September 30, 2022

21,022
374
1,494
3,123
6,014
32,02915,129
352
1,338
3,964
6,580
27,365

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

232
1,040
5,174
57
6,504
33,870

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

5,174
4,445
176,568(2,479)7,488
191,197306
191,503
225,374(2) Consolidated Statements of Income(Millions of yen)Six months ended
September 30, 2021

Six months ended
September 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
Profit

71,53324,25447,27815,381
10,117369
340
21,808246
48
22,006
5,479
16,527

71,13627,99143,144
16,284
9,691
2,805
813
19,161297
60
19,398
4,170
15,228

Profit attributable toOwners of parent
Non-controlling interests
Profit16,5197
16,527

15,222515,228

Earnings per share
Basic earnings per share

245.27226.01-5-(Consolidated Statements of Comprehensive Income)(Millions of yen)Six months ended
September 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

Six months ended
September 30, 2022

16,527

15,228

(674)

(230)

(674)

(230)

(15)

(406)

Items that may be reclassified to profit or loss
Exchange differences on translation offoreign operations
Total of items that may be reclassified to
profit or loss
Total other comprehensive income
Comprehensive income

(15)

(406)

(690)
15,837(636)
14,591

Comprehensive income attributable toOwners of parent
Non-controlling interests
Comprehensive income

15,829715,837

14,585
5
14,591-6-

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

Balance at beginning of period
ProfitOther comprehensive income
Comprehensive income
Purchase of treasury shares
Dividends of surplus
Transfer from other components ofequity to retained earnings
Total transactions with owners
Balance at end of period

Financial
Exchange
assetsdifferences
measured aton
fair valuetranslation
through otherof foreign
comprehensive
operations
incomeSharecapitalCapitalsurplusRetainedearnings

Treasuryshares

5,174
-

4,445
-

146,796
16,51916,519(3,367)(2,476)
(0)
-

(93)
(15)
(15)
-

9,315
(674)
(674)
-

-

-

367

-

-

(367)

5,174

4,445

(2,999)160,315(0)(2,476)

(108)

(367)
8,272

Noncontrollin
ginterestsTotal

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
Transfer from other components ofequity to retained earnings
Total transactions with owners
Balance at end of period

9,221(690)(690)-

163,161
16,519(690)
15,829(0)(3,367)288
77-

163,449
16,527(690)
15,837(0)(3,367)

(367)

---

(367)
8,163

(3,367)
175,622295(3,367)
175,918-7-

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

Balance at beginning of period
ProfitOther comprehensive income
Comprehensive income
Purchase of treasury shares
Dividends of surplus
Transfer from other components ofequity to retained earnings
Total transactions with owners
Balance at end of period

Exchangedifferences
ontranslationof foreign
operations

Financial assets
measured at fairvalue throughothercomprehensive
income(2,478)
(0)
-

(253)
(406)
(406)
-

8,394
(230)
(230)
-

15-

-

(15)

(3,957)
176,568(0)(2,479)

(659)

(15)
8,148

Noncontrollin
ginterests

Total

Share
capitalCapitalsurplusRetainedearnings

Treasuryshares

5,174
-

4,445
-

165,303
15,222
15,222(3,973)

--

5,174

4,445

Equity attributable toowners of parent
Other
componentsof equity
Total
Total
Balance at beginning of period
ProfitOther comprehensive income
Comprehensive income
Purchase of treasury shares
Dividends of surplus
Transfer from other components ofequity to retained earnings
Total transactions with owners
Balance at end of period

8,140
(636)
(636)
-

180,585
15,222(636)
14,585(0)(3,973)300
55-180,886
15,228(636)14,591(0)(3,973)

(15)

---

(15)
7,488

(3,974)
191,197

306(3,974)
191,503-8-

(4) Consolidated Statements of Cash Flows(Millions of yen)Six months ended
September 30, 2021
Cash flows from operating activities
Profit before tax
Depreciation and amortization
Interest and dividend income
Interest expenses
Foreign exchange loss (gain)
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
Other
Net 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-

Six months ended
September 30, 2022

22,006
2,264
(246)
22
(0)

19,398
2,388
(297)
21
(1,463)303(1,187)

(188)

1,890

(1,484)(4,631)

(351)

(332)

(1,725)20,600246(10)(6,723)(14)
15,772297(21)(3,231)

14,11312,817(60)
30(1,272)(1,792)
(0)

(60)
30
(3,037)(1,488)(5,551)

1,157

4,223

2

1(1,935)(5,882)(795)(0)(3,365)(939)(0)(3,971)(4,161)(4,911)

(15)

859

7,999

2,883

57,88365,88360,56663,449Appendix：
Leading Products

Performance (consolidated)

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

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

2021(IFRS)

2022(IFRS)(estimated)

98,781

101,448

114,716116,637

121,859

137,484

141,000

15,28017,07920,644

21,66827,702

32,94830,000

16,244

17,451

21,54022,442

27,60833,30130,40011,74912,953

16,302

16,866

19,54024,98624,000(¥ million)
Brand nameVidazaActive Ingredientazacitidine

Indications

myelodysplastic
syndrome/
acute myeloid leukemia

Launch Date

Mar-2011/
Mar-2021

Viltepso(Japan)viltolarsen

Duchenne muscular
dystrophy

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

Sales 2020
(IFRS)

Sales 2021
(IFRS)

15,350

Sales 2022
Apr.-Sep.

Annual(estimated)

18,3389,139

14,6002,3877,750

6,856

14,700(1,953)(4,059)(2,090)(4,500)(434)(3,691)(4,765)(10,200)

Uptraviselexipag

pulmonary arterial
hypertension/
chronic thromboembolic
pulmonary hypertension

Nov-2016/
Aug-2021

6,804

8,400

4,921

10,300Tramal, Onetram

tramadolhydrochloride

cancer pain, chronic pain

Sep-2010

6,906

6,770

2,997

5,500

Gazyvaobinutuzumab

CD20-positive follicularlymphomaAug-2018

5,312

5,300

2,618

5,400

Zalutiatadalafil

urinary disorder causedby benign prostatic
hyperplasia

Apr-2014

6,743

4,106

1,4702,700

Cialistadalafil

erectile dysfunction

Jul-2009

2,677

2,532

1,439

2,850

Adcircatadalafil

pulmonary arterial
hypertension

Dec-2009

5,474

4,563

1,392

2,500

Defitelio

defibrotide sodium

sinusoidal obstruction
syndrome

Sep-2019

1,970

2,128

1,259

2,900

Erizasdexamethasone
cipecilate

allergic rhinitis

Dec-2009

2,444

2,330

674

2,400

Profit in co-promotion

8,442

8,934

5,005

9,500

Revenues from the licensing of industrial property rights

24,33833,207

14,46930,200

Pharmaceuticals

106,478

120,650

60,499119,500

Functional Food

15,38016,834

10,63721,500

Revenue

121,859

137,484

71,136141,000- 10 -Appendix：
Ｒ＆Ｄ Pipeline List
As of November 10. 2022

＜Domestic＞
Stage

Code No.
(Generic name)

Therapeutic fieldIndications

OriginDevelopment

LaunchPhase III

NS-065/NCNP-01 intractable disease・(viltolarsen)
orphan disease

Duchenne muscular
dystrophy

Co - development:
National Center of Neurology and Nippon Shinyaku
Psychiatry

Preparation forlaunchNS-32(ferricderisomaltose)

gynecology

iron deficiency anemia

Licensed - in fromPharmacosmos A/SNippon Shinyaku

Preparation forlaunchZX008(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 diseases

lupus 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)

relapsed/refractoryhematologic malignancies acute myeloid
leukemia

Licensed - in from
Delta-Fly Pharma, Inc.

Nippon Shinyaku

Preparation forPhase I

NS-161

inflammatory diseases

inflammatory diseases Nippon Shinyaku

Nippon Shinyaku

Preparation forPhase I

NS-025

urological diseases

urological diseases

Nippon Shinyaku

Nippon Shinyaku＜Overseas＞
StageU.S. Launch
Phase III

Code No.
(Generic name)

Therapeutic field

Indications

OriginDevelopment

NS-065/NCNP-01 intractable disease・(viltolarsen)
orphan disease

Duchenne muscular
dystrophy

Co - development:
National Center of Neurology and Nippon Shinyaku
Psychiatry

Phase IIICAP-1002

intractable disease・orphan disease

Duchenne muscular
dystrophy

Partnership:
Capricor Therapeutics, Inc.

Capricor Therapeutics, Inc.

Preparation forPhase II

NS-018(ilginatinib)

hematologic
malignancies

myelofibrosis

Nippon Shinyaku

Nippon Shinyaku- 11 -