Outline of Consolidated Financial Results for the First Quarter Ended June 30, 2023(IFRS)
August 10, 2023
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 14, 2023
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, 2023 (April 1, 2023 to June 30, 2023)(1) Operating results
RevenueThree months ended
June 30, 2023
Three months ended
June 30, 2022

Operating profit Profit before tax%
3.9

37,012%
8.6

11,16335,619 (13.1)

10,276 (37.9)

11,440%8.8

10,514 (37.3)(¥ million)
Profit attributable
ComprehensiveProfitto owners ofincome
parent%%%
8,751
6.0
8,749
6.1 10,705 28.7
8,253 (34.5)

8,249 (34.5)

8,315 (27.1)

Earnings per share (¥)
Basic
DilutedThree months ended
June 30, 2023
129.91－Three months ended
June 30, 2022
122.48－
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
202,799
202,48985.3%
195,933
195,625
82.4%

Total assets
As of June 30, 2023
As of March 31, 2023

237,408
237,451

2. Dividends
Annual dividends per share (¥)
st1 quarter
Year ended March 31, 2023
Year ending March 31, 2024
Year ending
March 31, 2024 (forecast)nd2 quarter－－rdYear-end

3 quarter

Annual57.00

－

57.00

114.00

60.00

－

60.00

120.003. Business Forecast for the Year Ending March 31, 2024 (April 1, 2023 to March 31, 2024)(¥ million)
RevenueFirst-half period
Full term

71,500145,000

Operating profit
%
0.5
0.5

16,00032,000%(16.5)
6.5-1-Profit before tax

16,20032,500%(16.5)
6.6

Net income
Basic earnings per
attributable toshare (¥)
owners of the parent
12,40025,000%(18.5)
9.6

184.10371.18

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, 2023:
70,251,484 shares
As of March 31, 2023:

70,251,484 shares

Number of shares of treasury stock
As of June 30, 2023:
As of March 31, 2023:

2,898,645 shares
2,898,610 shares

Average number of shares outstanding (total for the consolidated period)
As of June 30, 2023:
67,352,866 shares
As of June 30, 2022:

67,353,034 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 to
Nippon 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, 2023
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, 2023

60,04744,68636,358
11,554
5,225
157,873

55,25145,75235,518
11,568
6,680
154,771

32,215
17,1552,779
22,3083,241
1,877
79,578237,451

31,272
18,205
2,482
25,1192,776
2,780
82,636
237,408

(Millions of yen)
As of March 31, 2023
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 surplusRetained 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, 2023

20,538
314
1,516
6,131
6,682
35,183

16,361
338
1,410
2,283
8,262
28,655

232
1,148
4,895
57
6,334
41,518

232
971
4,691
57
5,953
34,6095,174
4,445
180,433(2,480)8,052
195,625307
195,933
237,451

5,174
4,445
185,344(2,480)10,006
202,489309
202,799
237,408

(2) Consolidated Statements of Income(Millions of yen)Three months ended
June 30, 2022

Three months ended
June 30, 2023

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
Profit35,61913,92821,690
8,200
4,738
1,652
128
10,276266
28
10,5142,260
8,253

37,012
12,962
24,050
8,418
5,911
1,572
129
11,163298
21
11,4402,688
8,751

Profit attributable toOwners of parent
Non-controlling interests
Profit8,249
48,2538,749
28,751

Earnings per share
Basic earnings per share

122.48129.91-5-(Consolidated Statements of Comprehensive Income)(Millions of yen)Three months ended
June 30, 2022
ProfitOther comprehensive income
Items that will not be reclassified to profit or loss
Financial assets measured at fair value through othercomprehensive income
Total of items that will not be reclassified to profit orloss

Three months ended
June 30, 2023
8,253

8,751

319

1,955

319

1,955

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

(258)

(2)

(258)
61
8,315

(2)
1,953
10,705Comprehensive income attributable toOwners of parent
Non-controlling interests
Comprehensive income

8,310
4
8,315

10,703
2
10,705-6-

(3) Consolidated Statements of Changes in Net Assets
For the three-month period ended June 30,2022(Millions of yen)
Equity attributable to owners of parent
Other components of equity

Share capital

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

5,174
5,174

Capitalsurplus

4,445
4,445

Equity attributable to ownersof parent
Othercomponents ofequity
Total

Retainedearnings

Treasuryshares

165,303
8,249
8,249(3,973)(3,973)
169,579(2,478)(0)(0)(2,479)Noncontrollig
interests

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 period8,140
61
61
8,202

180,5858,249
61
8,310(0)(3,973)(3,974)
184,922-7-30044305

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

Exchangedifferences ontranslation offoreign
operations

Financial assets
measured at fair value
through othercomprehensive income

(253)
(258)
(258)
(512)

8,394
319
319
8,714

For the three-month period ended June 30,2023(Millions of yen)
Equity attributable to owners of parent
Other components of equity

Share capital

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

5,174
5,174

Capitalsurplus

4,445
4,445

Equity attributable to ownersof parent
Other
components ofequityTotal

Retainedearnings

Treasuryshares180,433
8,749
8,749(3,839)(3,839)185,344(2,480)(0)(0)(2,480)Noncontrollig
interests

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

8,052
1,953
1,953
10,006

195,625
8,749
1,953
10,703(0)(3,839)(3,839)202,489-8-30722309

195,933
8,751
1,953
10,705(0)(3,839)(3,839)202,799

Exchangedifferences ontranslation offoreign
operations

Financial assets
measured at fair value
through othercomprehensive income

(616)
(2)
(2)
(619)

8,669
1,955
1,955
10,625

(4) Consolidated Statements of Cash Flows(Millions of yen)Three months ended
June 30, 2022
Cash flows from operating activities
Profit before taxDepreciation and amortization
Interest and dividend income
Interest expenses
Foreign exchange loss (gain)
Loss (gain) on sale of fixed assets
Decrease (increase) in trade and other receivables
Decrease (increase) in inventories
Increase (decrease) in trade and other payables
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 of investments
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, 2023

10,514
1,221(266)
15(720)15(2,392)
1,508(4,750)
(175)
2,096
7,065
266
(8)
(3,451)
3,872

11,4401,236(298)
5(940)
31(899)948(4,425)
(204)
270
7,165
296
(5)
(6,930)526(45)30(860)(1,243)(1,850)2,400
1(1,566)(45)
30(1,661)
(385)
(0)
－
1
(2,060)(535)(0)(3,753)(4,289)(422)(0)(3,625)(4,047)331

786(1,651)60,566
58,915(4,795)60,04755,251

Appendix：
Ｌｅａｄｉｎｇ Ｐｒｏｄｕｃｔｓ

August 10. 2023

Performance (consolidated)

Revenue
Operating profit
Profit before tax
Profit attributable toowners of parent(¥ million)
2023(IFRS)(estimated)

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

2021(IFRS)

2022(IFRS)

101,448

114,716

116,637

121,859

137,484

144,175

145,000

17,07920,644

21,66827,202

32,94830,04932,00017,451

21,54022,442

27,60833,301

30,48932,50012,953

16,302

16,866

19,54024,986

22,81225,000(¥ million)
Brand name

Active Ingredient

Indications

Launch Date

Viltepso(Japan)viltolarsen

Duchenne musculardystrophy

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

Sales 2023 (IFRS)Sales 2021
(IFRS)

Sales 2022
(IFRS)

Apr-JunApr-Sep(estimated)

Annual(estimated)

7,750

14,341

4,165

8,500

18,300(4,059)(4,139)(1,051)(2,200)(4,800)(3,691)(10,201)(3,113)(6,300)(13,500)

Uptraviselexipag

pulmonary arterial
hypertension/
chronic thromboembolic
pulmonary hypertension

Nov-2016/
Aug-2021

8,400

10,543

3,255

6,400

14,000Vidazaazacitidine

myelodysplastic
syndrome/
acute myeloid leukemia

Mar-2011/
Mar-2021

18,33815,951

2,871

5,700

10,500

Gazyvaobinutuzumab

CD20-positive follicularlymphoma/
CD20-positive chronic
lymphocytic leukemia

Aug-2018/
Dec-2022

5,300

4,904

1,220

2,300

4,900

Tramal, Onetram

tramadolhydrochloride

cancer pain, chronic pain

Sep-2010

6,770

5,358

1,104

2,250

4,300

Cialistadalafil

erectile dysfunction

Jul-2009

2,532

2,938

654

1,150

2,500

Adcircatadalafil

pulmonary arterial
hypertension

Dec-2009

4,563

2,649

631

1,100

2,100

Defitelio

defibrotide sodium

sinusoidal obstruction
syndrome

Sep-2019

2,128

2,524

631

1,400

3,000Zalutia

tadalafil

urinary disorder causedby benign prostatic
hyperplasia

Apr-2014

4,106

2,826

614

1,050

2,000

Erizasdexamethasone
cipecilate

allergic rhinitis

Dec-2009

2,330

2,640

334

900

2,500

Profit in co-promotion

8,934

9,520

2,310

4,600

9,300

Revenues from the licensing of industrial property rights

33,20730,714

9,104

17,20035,000

Pharmaceuticals

120,650

121,988

30,87060,500123,500

Functional Food

16,834

22,187

6,142

11,00021,500

Revenue

137,484

144,175

37,012

71,500145,000- 10 -

Appendix：
Ｒ＆Ｄ Pipeline List
As of August 10. 2023

＜Domestic＞
Stage

Code No.
(Generic name)

Therapeutic fieldIndications

OriginDevelopment

LaunchPhase III

NS-065/NCNP-01(viltolarsen)

intractable disease・orphan
Duchenne muscular dystrophy
diseaseCo - development:
National Center of Neurology andPsychiatry

Nippon Shinyaku

NDA filing

NS-87(daunorubicin /cytarabine)

hematologic malignancies

Licensed - in from
Jazz Pharmaceuticals plc

Nippon Shinyaku

NDA filing

ZX008(fenfluraminehydrochloride)

intractable disease・orphan
Lennox-Gastaut syndrome
diseaseDistribution partnership: UCB S.A.
(former : Zogenix, Inc.)UCB S.A.
(former : Zogenix, Inc.)

Phase III

ZX008
(fenfluraminehydrochloride)

intractable disease・orphan
CDKL5 deficiency disorderdiseaseDistribution partnership: UCB S.A.
(former : Zogenix, Inc.)UCB S.A.
(former : Zogenix, Inc.)

Phase IIIGA101
(obinutuzumab)

intractable disease・orphan
lupus nephritis
diseaseLicensed - in from
Chugai Pharmaceutical Co., Ltd.

Co - development:
Chugai Pharmaceutical Co., Ltd.

Phase IIIGA101
(obinutuzumab)

intractable disease・orphan
pediatric nephrotic syndrome
diseaseLicensed - 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
diseasepediatric pulmonary arterial
hypertension

Nippon Shinyaku

Co - development:
Janssen Pharmaceutical K.K.

Phase II

NS-580gynecology

endometriosis

Nippon Shinyaku

Nippon Shinyaku

Phase II

NS-580urological diseases

chronic prostatitis / chronic pelvic
pain syndrome

Nippon Shinyaku

Nippon Shinyaku

high-risk acute myeloid leukemia

Preparation for Phase II

NS-089/NCNP-02(brogidirsen)

intractable disease・orphan
Duchenne muscular dystrophy
diseaseCo - development:
National Center of Neurology andPsychiatry

Nippon Shinyaku

Preparation for Phase II

NS-229intractable disease・orphan eosinophilic granulomatosis withdiseasepolyangiitis

Nippon Shinyaku

Nippon Shinyaku

Licensed - in fromThe Menarini Group

Nippon Shinyaku

Co - development:
National Center of Neurology andPsychiatry

Nippon Shinyaku

NS-401(tagraxofusp)

Phase I/II

hematologic malignancies

blastic plasmacytoid dendritic cellneoplasm

Preparation for Phase I/IINS-050/NCNP-03

intractable disease・orphan
Duchenne muscular dystrophy
diseasePhase I

NS-917(radgocitabine)

hematologic malignancies

relapsed/refractory acute myeloid
leukemia

Licensed - in from
Delta-Fly Pharma, Inc.

Nippon Shinyaku

Phase I

NS-161

inflammatory diseases

inflammatory diseases

Nippon Shinyaku

Nippon Shinyaku

Phase I

NS-025

urological diseases

urological diseases

Nippon Shinyaku

Nippon Shinyaku＜Overseas＞

Stage

Code No.
(Generic name)

Therapeutic field

Indications

OriginDevelopment

US Launch
Phase III

NS-065/NCNP-01(viltolarsen)

intractable disease・orphan
Duchenne muscular dystrophy
diseaseCo - development:
National Center of Neurology andPsychiatry

Nippon Shinyaku

Phase IIICAP-1002

intractable disease・orphan
Duchenne muscular dystrophy
diseasePartnership:
Capricor Therapeutics, Inc.

Capricor Therapeutics, Inc.

Phase II

NS-018(ilginatinib)

hematologic malignancies

Nippon Shinyaku

Nippon Shinyaku

myelofibrosis

Preparation for Phase II

NS-089/NCNP-02(brogidirsen)

intractable disease・orphan
Duchenne muscular dystrophy
diseaseCo - development:
National Center of Neurology andPsychiatry

Nippon Shinyaku

Preparation for Phase II

NS-229intractable disease・orphan eosinophilic granulomatosis withdiseasepolyangiitis

Nippon Shinyaku

Nippon Shinyaku

Preparation for Phase I/II

NS-050/NCNP-03

intractable disease・orphan
Duchenne muscular dystrophy
diseaseCo - development:
National Center of Neurology andPsychiatry

Nippon Shinyaku- 11 -