Outline of Consolidated Financial Results for the Year Ended March 31, 2024(IFRS)
May 10, 2024
Name of the listed company: NIPPON SHINYAKU CO., LTD.
Code No.: 4516
Representative: Toru Nakai, President and Representative Director
Contact: Hideyuki Fujii, Department Manager and Finance & Accounting Dept.
Scheduled date of annual general meeting of shareholders: June 27, 2024
Scheduled date to commence dividend payments: June 28, 2024
Scheduled date to file annual securities report: June 28, 2024
Preparation of supplementary material on financial results: Yes
Financial result meeting: Yes (for institutional investors and securities analysts)

Listing stock exchange: Tokyo
URL https://www.nippon-shinyaku.co.jp/
Tel. +81-75-321-9116* All amounts are rounded down to the nearest million yen.
1. Consolidated Results for the Year Ended March 31, 2024 (April 1, 2023 to March 31, 2024)(1) Operating results
RevenueYear ended
March 31, 2024
Year ended
March 31, 2023

Operating profit Profit before tax

148,255%
2.8

33,295%10.8

144,175

4.9

30,049 (8.8)

DilutedYear ended March 31, 2024
383.82
Year ended March 31, 2023
338.70Note: Equity-method investments: not applicable%
10.3

30,489 (8.4)

Return on equity
attributable to ownersof parent
12.4%
12.1%

Earnings per share (¥)
Basic33,616－－(2) Financial position
Total assets
As of March 31, 2024
As of March 31, 2023

22,819 (8.7)

22,812 (8.7)

Profit before tax
to total assets

Operating profit
to revenue

13.4%
13.3%

22.5%
20.8%

(¥ million)
Ratio of equity
Equity attributable
attributable toto owners of parent
owners of parent toper share
total assets(¥)
220,224
83.6%
3,269.72
195,62582.4%
2,904.49

220,534
195,933(3) Cash flows

Year ended March 31, 2024
Year ended March 31, 2023

22,861 (5.7)

Total equity
attributable toowners of parent

Total equity

263,404
237,451(¥ million)
Profit attributable
Comprehensive
Profitto owners ofincomeparent%%%25,853 13.3
25,851 13.3 32,616 42.7(¥ million)
Cash flows fromoperating activities
16,28926,170Cash flows frominvesting activities(9,921)（17,631)

Cash flows fromfinancing activities(9,719)(9,605)

Cash and cash
equivalents at year-end
58,09460,047

2. Dividends
Dividends as a
Total dividends
Payout ratio percentage of net(full term)(consolidated)assets(¥ million)
Annual(consolidated)
114.00
7,678
33.7%
4.1%

Annual dividends per share (¥)
nd

2 quarterYear-end

Year ended March 31, 2023

57.00

57.00

Year ended March 31, 2024

62.00

62.00

124.00Year ending
March 31, 2025forecast)

62.00

62.00

124.00

8,351

32.3%

4.0%

34.1%

3. Business Forecast for the Year Ending March 31, 2025 (April 1, 2024 to March 31, 2025)

RevenueFirst-half period
Full term

73,300150,000

%
(0.0)
1.2

Operating profit

12,50031,000%(40.1)(6.9)-1-(¥ million)
Net income
Basic earnings per
Profit before tax
attributable toshare (¥)
owners of the parent%%
12,7009,900
146.99(39.9)(38.8)
31,500(6.3) 24,500(5.2)
363.76

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 March 31, 2024:
As of March 31, 2023:
Number of shares of treasury stock
As of March 31, 2024:
As of March 31, 2023:

70,251,484 shares
70,251,484 shares
2,898,726 shares
2,898,610 shares

Average number of shares outstanding (total for the consolidated period)
As of March 31, 2024:
67,352,808 shares
As of March 31, 2023:

67,352,967 shares

Note:
This summary of financial results is exempt from the audit procedures under the Financial Instruments and Exchange Act. At the timeof disclosure, published figures in this financial release have not been completed to a review of financial statements based on the
Financial Instruments and Exchange Law.
The above forecasts are based on data available as of the date of release of this document as well as assumptions based on uncertain
factors, which might have a material effect on the Company’s performance in the future. 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 March 31, 2024

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

58,09447,237
39,111
10,6099,232
164,285

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

33,58225,1202,971
32,862
1,766
2,817
99,119263,404

(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 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 March 31, 2024

20,538
314
1,516
6,131
6,682
35,18324,706
372
1,720
3,594
6,941
37,336

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

232
1,152
4,090
58
5,533
42,8705,174
4,445
180,433(2,480)8,052
195,625307
195,933
237,451

5,174
4,445
198,260(2,480)14,825220,224310
220,534
263,404

(2) Consolidated Statements of Income(Millions of yen)
Fiscal year ended
March 31, 2023

Fiscal year ended
March 31, 2024

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
Profit144,175
55,98088,19534,812
24,1351,908
1,106
30,049575
136
30,4897,669
22,819148,255
50,234
98,021
34,95931,676
3,163
1,252
33,295650
329
33,616
7,762
25,853

Profit attributable to
Owners of parent
Non-controlling interests
Profit22,812
7
22,81925,851
2
25,853

Earnings per share
Basic earnings per share

338.70383.82-5-

(Consolidated Statements of Comprehensive Income)(Millions of yen)
Fiscal year ended
March 31, 2023
ProfitOther comprehensive income
Items that will not be reclassified to profit or loss
Financial assets measured at fair value through othercomprehensive income
Remeasurements of defined benefit plans
Total of items that will not be reclassified to profit orloss

Fiscal year ended
March 31, 2024

22,81925,853

516

6,649

(111)

(14)

404

6,634

(362)

128

Items that may be reclassified to profit or loss
Exchange differences on translation of foreign
operations
Total of items that may be reclassified to profit or loss
Other comprehensive income, net of tax
Comprehensive income

(362)
41
22,861

128
6,762
32,616Comprehensive income attributable to
Owners of parent
Non-controlling interests
Comprehensive income

22,854
7
22,861

32,6142
32,616-6-

(3) Consolidated Statements of Changes in Net Assets
Fiscal year ended March 31,2023(Millions of yen)
Equity attributable to owners of parent
Other components of equity
Share capital

CapitalsurplusRetainedearnings

TreasurysharesBalance at beginning of period
Profit

5,174
-

4,445
-

165,303
22,812Other comprehensive income

-

-

-

Total

(2,478)

8,394
-

(362)

516

(362)

516

-

-

-

-

-

129

-

-

(7,683)

(1)

-

(241)

-

22,812--0-

Dividends of surplus
Transfer from other components of

-

-

-

-

(7,812)

(1)
0

-

0

5,174

4,445

Balance at end of period

(253)
-

-

-

Total transactions with owners

Financial assets
measured at fairvalue through othercomprehensive
income-Purchase of treasury shares
Disposal of treasury shares

equity to retained earnings

Exchangedifferences ontranslation offoreign
operations(2,480)180,433

(241)

(616)

8,669

Equity attributable to owners of parent
Other components of equity
Remeasurementsof defined benefit
plans

Non-controllinginterests

Total

Total

Total

Balance at beginning of period
Profit-8,140-

Other comprehensive income

(111)

41

41

-

41

(111)

41

22,854

7

22,861

-

-

-

-

-

(1)
0

(1)
0

111

-

-

111

(129)

-

8,052

(7,814)307

Total
Purchase of treasury shares
Disposal of treasury shares
Dividends of surplus
Transfer from other components ofequity to retained earnings
Total transactions with owners
Balance at end of period

(129)

-7-

180,585
22,812(7,812)

195,625

300
7

-

-

180,886
22,819(7,812)-(7,814)

195,933

Fiscal year ended March 31,2024(Millions of yen)
Equity attributable to owners of parent
Other components of equity
Share capital

CapitalsurplusRetainedearnings

Balance at beginning of period

5,174

4,445

180,433

ProfitOther comprehensive income--

25,851-

Total
Purchase of treasury shares--

25,851-

Disposal of treasury shares
Dividends of surplus--

Transfer from other components ofequity to retained earnings--(8,014)

-

-

5,174

4,445

Total transactions with owners
Balance at end of period

Exchangedifferences ontranslation offoreign
operations

Financial assets
measured at fairvalue through othercomprehensive
income(2,480)

(616)

8,669

128

6,649

(0)

128
-

6,649
-

-

-

-

-

-

(0)

-

(5)

Treasuryshares-(9)(8,024)(2,480)198,260

(5)

(488)

15,313Equity attributable to owners of parent
Other components of equity
Remeasurementsof defined benefit
plans

Non-controllinginterests

Total

Total

Total

Balance at beginning of period

-

8,052

195,625307

195,933

ProfitOther comprehensive income

(14)

6,762

25,8516,762

2-25,853
6,762

Total
Purchase of treasury shares

(14)
-

6,762
-

32,614(0)

2-

32,616(0)

Disposal of treasury shares
Dividends of surplus--(8,014)-(8,014)

Transfer from other components ofequity to retained earnings

14

9

-

-

-

Total transactions with owners

149(8,015)-(8,015)

Balance at end of period-

14,825220,224310

220,534-8-

(4) Consolidated Statements of Cash Flow
(Millions of yen)
Fiscal year ended
March 31, 2023
Cash flows from operating activities
Profit before tax
Depreciation and amortization
Interest and dividend income
Interest expenses
Foreign exchange loss (gain)
Loss on retirement 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
Other
Net cash provided by (used in) investing activities
Cash flows from financing activities
Repayments of lease liabilities
Purchase of treasury shares
Proceeds from sale 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-

Fiscal year ended
March 31, 2024

30,489
5,041
(575)
50
(1,165)87(1,425)
1,782
81
(771)
(781)
32,815575(50)(7,169)26,17033,616
5,023
(650)
20
(1,479)104(2,225)(2,580)(706)(862)(2,859)27,401654(20)(11,744)
16,289(1,162)
1,102(5,660)(6,068)(11,918)
6,064
11(17,631)(1,622)
1,462(5,058)(4,591)(10,500)
10,380
7(9,921)(1,794)(1)
0(7,809)(9,605)547(518)
60,56660,047(1,706)(0)－(8,011)(9,719)1,397(1,953)60,04758,094

May 10. 2024

Ｎｉｐｐｏｎ Ｓｈｉｎｙａｋｕ：Ｌｅａｄｉｎｇ Ｐｒｏｄｕｃｔｓ

Performance (consolidated)(¥ million)
2024(IFRS)(estimated)

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

2021(IFRS)

2022(IFRS)

2023(IFRS)

Revenue

114,716

116,637

121,859

137,484

144,175

148,255

150,000

Operating profit

20,644

21,66827,702

32,94830,04933,29531,000

Profit before tax

21,54022,442

27,60833,301

30,48933,61631,500

Profit attributable toowners of parent

16,302

16,866

19,54024,986

22,81225,851

24,500(¥ million)
Brand name

Active Ingredient

Indications

Launch Date

Sales 2022
(IFRS)

Sales 2023
(IFRS)

14,341

Viltepso(Japan)viltolarsen

Duchenne muscular
dystrophy

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

Sales 2024 (IFRS)(estimated)
Apr-Sep

Annual

17,5309,800

20,100(4,139)(4,407)(2,300)(4,600)(10,201)(13,123)(7,500)(15,500)

Uptraviselexipag

pulmonary arterial
hypertension/
chronic thromboembolic
pulmonary hypertension

Nov-2016/
Aug-2021

10,543

12,9187,600

15,400Vidazaazacitidine

myelodysplastic
syndrome/
acute myeloid leukemia

Mar-2011/
Mar-2021

15,951

10,383

2,600

4,800

Gazyvaobinutuzumab

CD20-positive follicularlymphoma/
CD20-positive chronic
lymphocytic leukemia

Aug-2018/
Dec-2022

4,904

4,695

2,500

5,100

Tramal, Onetram

tramadol hydrochloride

cancer pain, chronic pain

Sep-2010

5,358

3,927

1,400

2,700

Cialistadalafil

erectile dysfunction

Jul-2009

2,938

2,499

1,400

2,700

Erizasdexamethasone cipecilate allergic rhinitis

Dec-2009

2,640

2,284

700

2,100

Zalutiatadalafil

urinary disorder causedby benign prostatic
hyperplasia

Apr-2014

2,826

2,256

850

1,600

Adcircatadalafil

pulmonary arterial
hypertension

Dec-2009

2,649

2,255

900

1,700

Defitelio

defibrotide sodium

sinusoidal obstruction
syndrome

Sep-2019

2,524

2,221

1,100

2,300

Profit in co-promotion

9,520

8,658

4,550

9,100

Revenues from the licensing of industrial property rights

30,71440,30420,60041,700

Pharmaceuticals

121,988

125,105

62,800128,500

Functional Food

22,18723,15010,50021,500

Revenue

144,175

148,255

73,300150,000- 10 -

Ｎｉｐｐｏｎ Ｓｈｉｎｙａｋｕ：Ｒ＆Ｄ Pipeline List

May 10. 2024

＜Domestic＞
Stage

Code No.
(Generic name)

Therapeutic field

Indications

OriginDevelopment

LaunchPhase III

NS-065/NCNP-01(viltolarsen)

intractable disease・orphan
Duchenne muscular dystrophy
diseaseNippon Shinyaku

Preparation for launch

NS-87(daunorubicin /cytarabine)

Co - development:
National Center of Neurology andPsychiatry

hematologic malignancies

high-risk acute myeloid leukemia

Licensed - in from
Jazz Pharmaceuticals plc

Nippon Shinyaku

NDA filing

NS-304(selexipag)

intractable disease・orphan
diseasepediatric pulmonary arterial
hypertension

Nippon Shinyaku

Co - development:
Janssen Pharmaceutical K.K.

NDA filing
Phase III

LY3527727(pirtobrutinib)

hematologic malignancies

Mantle cell lymphoma

Alliance agreement in Japan : Eli LillyJapan

Eli Lilly Japan

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 IIIGA101
(obinutuzumab)

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

Co - development:
Chugai Pharmaceutical Co., Ltd.

Phase III

LY3527727(pirtobrutinib)

hematologic malignancies

Chronic lymphocytic leukemia

Alliance agreement in Japan : Eli LillyJapan

Eli Lilly Japan

Phase II

NS-304(selexipag)

cardiovasculararteriosclerosis obliterans

Nippon Shinyaku

Nippon Shinyaku

Phase II

NS-580gynecology

endometriosis

Nippon Shinyaku

Nippon Shinyaku

Phase II

NS-580urological diseases

chronic prostatitis/chronic pelvic pain
Nippon Shinyaku
syndrome

Nippon Shinyaku

Phase II
Preparation for Phase
II
Phase I/II

NS-089/NCNP-02(brogidirsen)

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

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)

hematologic malignancies

blastic plasmacytoid dendritic cell
neoplasm

Nippon Shinyaku

Preparation for Phase
I/II

NS-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-025

urological diseases

urological diseases

Nippon Shinyaku

Nippon Shinyaku

Phase I

NS-863

cardiovascularcardiovascular diseases

Nippon Shinyaku

Nippon Shinyaku＜Overseas＞
Stage

Code No.
(Generic name)

Therapeutic field

Indications

OriginCo - development:
National Center of Neurology andPsychiatry
Partnership:
Capricor Therapeutics, Inc.

Development

US Launch
Phase III

NS-065/NCNP-01(viltolarsen)

intractable disease・orphan
Duchenne muscular dystrophy
diseasePhase IIICAP-1002

intractable disease・orphan
Duchenne muscular dystrophy
diseasePhase II

NS-089/NCNP-02(brogidirsen)

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

Nippon Shinyaku

NS-229intractable disease・orphan Eosinophilic granulomatosis withdiseasepolyangiitis

Nippon Shinyaku

Nippon Shinyaku

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

Nippon Shinyaku

Preparation for Phase
II
Preparation for Phase
I/II

NS-050/NCNP-03- 11 -

Nippon Shinyaku
Capricor Therapeutics, Inc.