Outline of Consolidated Financial Results for the Third Quarter Ended December 31, 2022
(IFRS)
February 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: February 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 December 31, 2022 (April 1, 2022 to December 31, 2022)(1) Operating results(¥ million)
Profit attributable
Comprehensive
Revenue
Operating profit Profit before tax
Profitto owners ofincome
parentThird 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
Third quarter ended
December 31, 2021
106,292
23,062－ 30,353－ 30,722－ 23,072－－ 22,077－
Earnings per share (¥)
Basic
DilutedThird quarter ended
December 31, 2022
336.65－
Third quarter ended
December 31, 2021
342.41－
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
195,968
195,660
84.4%
180,886
180,585
82.1%

Total assets
As of December 31, 2022
As of March 31, 2022

231,876
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 quarterrd51.00
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%(3.9)

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 December 31, 2022:
70,251,484 shares
As of March 31, 2022:

70,251,484 shares

Number of shares of treasury stock
As of December 31, 2022:
As of March 31, 2022:

2,898,549 shares
2,898,434 shares

Average number of shares outstanding (total for the consolidated period)
As of December 31, 2022:
67,352,988 shares
As of December 31, 2021:

67,353,253 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 December 31, 2022

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

54,91951,60737,357
9,517
5,026
158,427

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

31,16015,592
2,228
22,435147
1,884
73,448
231,876(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 December 31, 2022

21,022
374
1,494
3,123
6,014
32,02920,517
1,156
1,237
1,217
5,612
29,740

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

232
873
5,003
57
6,167
35,9085,174
4,445
165,303(2,478)8,140
180,585300
180,886
219,943

5,174
4,445
180,406(2,479)8,114
195,660
307
195,968
231,876

(2) Consolidated Statements of Income(Millions of yen)
Nine months ended
December 31, 2021

Nine months ended
December 31, 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
Profit106,292
37,52068,771
23,23915,541871
509
30,353452
82
30,722
7,650
23,072

109,919
42,55667,363
24,791
15,135
1,492
941
27,987533
98
28,422
5,741
22,681

Profit attributable toOwners of parent
Non-controlling interests
Profit23,062
10
23,072

22,674
722,681

Earnings per share
Basic earnings per share

342.41

336.65-5-(Consolidated Statements of Comprehensive Income)(Millions of yen)
Nine months ended
December 31, 2021
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

Nine months ended
December 31, 2022

23,072

22,681

(921)

566

(921)

566

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

(73)

(352)

(73)
(995)
22,077(352)
214
22,895Comprehensive income attributable toOwners of parent
Non-controlling interests
Comprehensive income

22,066
10
22,07722,888722,895-6-

(3) Consolidated Statements of Changes in Net Assets
For the nine-month period ended December 31,2021(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

CapitalsurplusRetainedearnings

TreasurysharesExchange
Financial assets
differences on measured at fairtranslation of value through otherforeigncomprehensive
operations
income

5,174
-

4,445
-

146,796
23,062
23,062(6,802)(2,476)
(1)
-

(93)
(73)
(73)
-

9,315
(921)
(921)
--

-

367

--

(367)

5,174

4,445

(6,434)
163,423(1)(2,477)

(166)

(367)
8,025

Noncontrollinginterests

Total

Equity attributable to ownersof parent
Othercomponents ofequity
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
(995)
(995)
-

163,161
23,062(995)
22,066(1)(6,802)

288
1010-

163,449
23,072(995)
22,077(1)(6,802)

(367)

---

(367)
7,858

(6,804)
178,424298(6,804)
178,723-7-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 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

CapitalsurplusRetainedearnings

TreasurysharesExchange
Financial assets
differences measured at fair value
on translation
through otherof foreign
comprehensiveoperations
income5,174-4,445-

165,30322,674
22,674(7,812)(2,478)
(0)
-

(253)
(352)
(352)
-

8,394
566
566
---

241

-

-

(241)

5,174

4,445

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

(606)

(241)
8,720

Noncontrollinginterests

Total

Equity attributable to ownersof parent
Other
components ofequityTotal
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
214
214-180,585
22,674
214
22,888(0)(7,812)300
77-

180,886
22,681
214
22,895(0)(7,812)

(241)

---

(241)
8,114

(7,813)
195,660

307(7,813)
195,968-8-

(4) Consolidated Statements of Cash Flows(Millions of yen)
Nine months ended
December 31, 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 other receivables
Decrease (increase) in inventories
Increase (decrease) in trade and other payablesIncrease (decrease) in retirement benefit liability
OtherSubtotal
Interest 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 sharesDividends 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-Nine months ended
December 31, 2022

30,722
3,424
(452)
40
(2)
(9,228)(2,187)315(521)(2,127)
19,984451(21)(11,295)
9,119

28,422
3,679
(533)
31
(457)
(8,363)776(2,814)(502)(979)
19,258533(31)(7,142)
12,618(385)
40(2,010)(2,348)(501)
1,657
1(3,545)(85)
40(4,354)(1,176)(9,449)5,594
8(9,421)(1,183)(1)(6,605)(7,790)(1,322)(0)(7,599)(8,922)(68)

78(2,285)57,88355,597(5,647)60,56654,919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

114,716

116,637

121,859

137,484

141,000

15,28017,07920,644

21,66827,202

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 (IFRS)
Apr-Dec

Annual(estimated)

18,33813,04714,600

2,387

7,750

10,717

14,700(1,953)(4,059)(3,188)(4,500)(434)(3,691)(7,528)(10,200)

Uptraviselexipag

pulmonary arterial
hypertension/
chronic thromboembolic
pulmonary hypertension

Nov-2016/
Aug-2021

6,804

8,400

7,984

10,300Tramal, Onetram

tramadolhydrochloride

cancer pain, chronic pain

Sep-2010

6,906

6,770

4,349

5,500

Gazyvaobinutuzumab

CD20-positive follicularlymphoma/
CD20-positive chronic
lymphocytic leukimia

Aug-2018/
Dec-2022

5,312

5,300

3,918

5,400

Cialistadalafil

erectile dysfunctionJul-2009

2,677

2,532

2,287

2,850

Zalutiatadalafil

urinary disorder causedby benign prostatic
hyperplasia

Apr-2014

6,743

4,106

2,233

2,700

Adcircatadalafil

pulmonary arterial
hypertension

Dec-2009

5,474

4,563

2,117

2,500

Defitelio

defibrotide sodium

sinusoidal obstruction
syndrome

Sep-2019

1,970

2,128

2,041

2,900

Erizasdexamethasone
cipecilate

allergic rhinitis

Dec-2009

2,444

2,330

1,146

2,400

Profit in co-promotion

8,442

8,934

7,634

9,500

Revenues from the licensing of industrial property rights

24,33833,20722,60730,200

Pharmaceuticals

106,478

120,650

93,095

119,500

Functional Food

15,38016,834

16,82421,500

Revenue

121,859

137,484

109,919

141,000- 10 -Appendix：
Ｒ＆Ｄ Pipeline List
As of February 10. 2023

＜Domestic＞
Stage

Code No.
(Generic name)

Therapeutic field

Indications

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 forlaunch

NS-32(ferricderisomaltose)

gynecology

iron deficiency anemia

Licensed - in fromPharmacosmos A/S

Nippon Shinyaku

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)Phase I

NS-161

inflammatory diseases

inflammatory diseases Nippon Shinyaku

Nippon Shinyaku

Phase I

NS-025

urological diseases

urological diseases

Nippon Shinyaku

relapsed/refractoryhematologic malignancies acute myeloid
leukemia

Licensed - in from
Delta-Fly Pharma, Inc.

Nippon Shinyaku

Nippon Shinyaku＜Overseas＞
Stage
US Launch
Phase III

Code No.
(Generic name)

Therapeutic field

Indications

OriginDevelopment

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

Duchenne musculardystrophy

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

Duchenne muscular
dystrophy

Partnership:
Capricor Therapeutics, Inc.

Capricor Therapeutics, Inc.

Nippon Shinyaku

Nippon Shinyaku

Phase IIICAP-1002

intractable disease・orphan disease

Phase II

NS-018(ilginatinib)

hematologic malignancies myelofibrosis- 11 -