Outline of Consolidated Financial Results for the Third Quarter Ended December 31, 2023
(IFRS)
February 9, 2024
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: February 14, 2024
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 December 31, 2023 (April 1, 2023 to December 31, 2023)(1) Operating results(¥ million)
Profit attributable
Comprehensive
Revenue
Operating profit Profit before tax
Profitto owners ofincome
parentThird quarter ended%%%%%%
December 31, 2023
112,728
2.6 30,450
8.8 30,973
9.0 24,004
5.8 24,002
5.9 27,398 19.7
Third quarter ended
December 31, 2022
109,919
3.4 27,987 (7.8) 28,422 (7.5) 22,681 (1.7) 22,674 (1.7) 22,895
3.7
Earnings per share (¥)
Basic
DilutedThird quarter ended
December 31, 2023
356.37－
Third quarter ended
December 31, 2022
336.65－
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
215,316
215,00786.8%
195,933
195,625
82.4%

Total assets
As of December 31, 2023
As of March 31, 2023

247,830
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)nd

2 quarter

rd57.00
62.00－－Year-end

3 quarter

Annual－57.00

114.00－62.00

124.003. Business Forecast for the Year Ending March 31, 2024 (April 1, 2023 to March 31, 2024)(¥ million)
Revenue

Full term

147,000

Operating profit%
2.0

33,500

%
11.5

-1-

Profit before tax

34,000%
11.5

Profit attributable
Basic earnings perto owners ofshare (¥)
parentt
26,000%14.0386.03

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

70,251,484 shares

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

2,898,706 shares
2,898,610 shares

Average number of shares outstanding (total for the consolidated period)
As of December 31, 2023:
67,352,821 shares
As of December 31, 2022:

67,352,988 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.
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 December 31, 2023

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

57,32347,507
38,8488,491
8,730
160,901

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

33,203
19,322
2,127
28,346
1,134
2,795
86,928247,830

(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 December 31, 2023

20,538
314
1,516
6,131
6,682
35,18319,089
1,143
1,297
696
4,966
27,193

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

232
751
4,277
58
5,319
32,513

5,174
4,445
180,433(2,480)8,052
195,625307
195,933
237,451

5,174
4,445
196,457(2,480)11,411215,007309
215,316
247,830

(2) Consolidated Statements of Income(Millions of yen)
Nine months ended
December 31, 2022Nine months ended
December 31, 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
Profit109,919
42,55667,363
24,791
15,135
1,492
941
27,987533
98
28,422
5,741
22,681

112,728
38,613
74,11425,741
19,5001,887
309
30,450611
89
30,973
6,968
24,004

Profit attributable toOwners of parent
Non-controlling interests
Profit

22,674
722,681

24,002
124,004

Earnings per share
Basic earnings per share

336.65356.37-5-(Consolidated Statements of Comprehensive Income)(Millions of yen)
Nine months ended
December 31, 2022
ProfitNine months ended
December 31, 2023

22,681

24,004

Other 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

566

3,355

566

3,355

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
Total other comprehensive income
Comprehensive income(352)

39(352)
214
22,89539
3,394
27,398Comprehensive income attributable toOwners of parent
Non-controlling interests
Comprehensive income

22,888
7
22,89527,397
1
27,398-6-

(3) Consolidated Statements of Changes in Net Assets
For the nine-month period ended December 31,2022(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
Transfer from other components ofequity to retained earnings
Total transactions with owners
Balance at end of period

Capitalsurplus

5,174
-

4,445
-

-

-

5,174

4,445

Equity attributable to ownersof parent
Other
components ofequity
Total

Exchangedifferences Financial assets measured
on translation at fair value through otherof foreign
comprehensive income
operations

Retainedearnings

Treasuryshares

165,303
22,674
22,674(7,812)(2,478)
(0)
-

(253)
(352)
(352)
-

8,394
566
566
-

241

-

-

(7,571)
180,406(0)(2,479)

(606)

(241)

Noncontrollinginterests

TotalTotal
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
214
214(241)
(241)
8,114

180,585
22,674
214
22,888(0)(7,812)

300
7
7-

--

(7,813)
195,660307-7-

180,886
22,681
214
22,895(0)(7,812)-(7,813)
195,968

(241)
8,720

For the nine-month period ended December 31,2023(Millions of yen)
Equity attributable to owners of parent
Other components of equity

Share capital

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

Capitalsurplus

5,174-

4,445---

5,174

4,445

Equity attributable to ownersof parent
Othercomponents ofequity
Total

Exchangedifferences Financial assets measured
on translation at fair value through otherof foreign
comprehensive income
operations

Retainedearnings

Treasuryshares180,433
24,002
24,002(8,014)(2,480)
(0)
-

(616)
3939-

8,669
3,355
3,355-

36--(7,978)
196,457(0)(2,480)

(577)

(36)

Noncontrollinginterests

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

8,052
3,394
3,394
(36)

(36)
11,411

195,625
24,0023,394
27,397(0)(8,014)

307
1
1---

(8,015)215,007309-8-

195,933
24,004
3,394
27,398(0)(8,014)-(8,015)
215,316(36)
11,988

(4) Consolidated Statements of Cash Flow
(Millions of yen)
Nine months ended
December 31, 2022
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 and retirement of fixed assets
Decrease (increase) in trade and other receivables
Decrease (increase) in inventoriesIncrease (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
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

Nine months ended
December 31, 2023

28,422
3,679(533)
31(457)43(8,363)
776(2,814)(502)(1,023)
19,258533(31)(7,142)
12,61830,973
3,695(611)
31(894)61(2,673)(2,433)(3,713)(617)(4,506)
19,311616(31)(11,769)
8,126

(85)
40(4,354)(1,176)(9,449)5,594
8(9,421)(85)
40(2,635)(1,833)(6,997)8,850
6(2,654)78(1,260)(0)(7,785)(9,046)849(5,647)60,56654,919(2,724)60,04757,323(1,322)(0)(7,599)(8,922)-9-Ｎｉｐｐｏｎ Ｓｈｉｎｙａｋｕ：Ｌｅａｄｉｎｇ Ｐｒｏｄｕｃｔｓ

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

147,000

17,07920,644

21,66827,202

32,94830,04933,50017,451

21,54022,442

27,60833,301

30,48934,00012,953

16,302

16,866

19,54024,986

22,81226,000February 9, 2024(¥ million)
Brand name

Active Ingredient

Indications

Launch Date

Sales 2021
(IFRS)

Sales 2022
(IFRS)

7,750

Viltepso(Japan)viltolarsen

Duchenne muscular
dystrophy

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

Sales 2023(IFRS)
Apr-Dec

Annual(estimated)

14,341

13,22518,300(4,059)(4,139)(3,332)(4,800)(3,691)(10,201)(9,892)(13,500)

Uptraviselexipag

pulmonary arterial
hypertension/
chronic thromboembolic
pulmonary hypertension

Nov-2016/
Aug-2021

8,400

10,543

10,02414,000Vidazaazacitidine

myelodysplastic
syndrome/
acute myeloid leukemia

Mar-2011/
Mar-2021

18,33815,951

8,329

10,200

Gazyvaobinutuzumab

CD20-positive follicularlymphoma/
CD20-positive chronic
lymphocytic leukimia

Aug-2018/
Dec-2022

5,300

4,904

3,692

4,900

Tramal, Onetram

tramadolhydrochloride

cancer pain, chronic
pain

Sep-2010

6,770

5,358

3,142

3,900

Cialistadalafil

erectile dysfunction

Jul-2009

2,532

2,938

1,946

2,500

Adcircatadalafil

pulmonary arterial
hypertension

Dec-2009

4,563

2,649

1,791

2,100

Zalutiatadalafil

urinary disorder causedby benign prostatic
hyperplasia

Apr-2014

4,106

2,826

1,788

2,200

Defitelio

defibrotide sodium

sinusoidal obstruction
syndrome

Sep-2019

2,128

2,524

1,712

2,300

Erizasdexamethasone
cipecilate

allergic rhinitis

Dec-2009

2,330

2,640

1,038

2,200

Profit in co-promotion

8,934

9,520

6,703

8,800

Revenues from the licensing of industrial property rights

33,20730,71428,89738,000

Pharmaceuticals

120,650

121,988

94,606125,000

Functional Food

16,834

22,187

18,121

22,000

Revenue

137,484

144,175

112,728

147,000- 10 -Ｎｉｐｐｏｎ Ｓｈｉｎｙａｋｕ：Ｒ＆Ｄ Pipeline List

Februaly 9. 2024

＜Domestic＞
Stage
LaunchPhase IIINDA filing
NDA filing
Phase III

Code No.
(Generic name)
NS-065/NCNP-01(viltolarsen)
NS-87(daunorubicin /cytarabine)
ZX008(fenfluraminehydrochloride)
ZX008(fenfluraminehydrochloride)

Therapeutic fieldIndicationsOrigin

Development

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

Nippon Shinyaku

hematologic malignancies

Licensed - in from
Jazz Pharmaceuticals plc

Nippon Shinyaku

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

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

high-risk acute myeloid leukemia

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 IINS-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
Nippon Shinyaku
syndrome

Nippon Shinyaku

Preparation for PhaseII

NS-089/NCNP-02(brogidirsen)

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

Preparation for Phase
IINS-229

intractable 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

Phase I/II

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 INS-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

Phase I

NS-863

cardiovascularcardiovascular 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
diseasePhase IIICAP-1002

intractable disease・orphan
Duchenne muscular dystrophy
diseaseCo - development:
National Center of Neurology andPsychiatry
Partnership:
Capricor Therapeutics, Inc.

Phase II

NS-018(ilginatinib)

hematologic malignancies

Nippon Shinyaku

Nippon Shinyaku

myelofibrosis

Nippon Shinyaku
Capricor Therapeutics, Inc.

Preparation for PhaseII

NS-089/NCNP-02(brogidirsen)

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

Nippon Shinyaku

Preparation for PhaseIINS-229

intractable 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
I/II

NS-050/NCNP-03- 11 -