Outline of Consolidated Financial Results for the First Quarter Ended June 30, 2024(IFRS)
August 7, 2024
Name of the listed company: NIPPON SHINYAKU CO., LTD.
Listing stock exchange: TokyoCode 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 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, 2024 (April 1, 2024 to June 30, 2024)(1) Operating results

39,131%
5.7

11,078%(0.8)

11,411%(0.3)(¥ million)
Profit attributable
ComprehensiveProfit
to owners ofincomeparent%%%10,270 17.3 10,264 17.3 11,104
3.7

37,012

3.9

11,163

8.6

11,4408.8

8,751

RevenueThree months ended
June 30, 2024
Three months ended
June 30, 2023

Operating profit Profit before tax

6.08,749

6.1

10,705

28.7

Earnings per share (¥)
Basic
DilutedThree months ended
June 30, 2024
152.40－Three months ended
June 30, 2023
129.91－
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
227,462
227,14785.4%
220,534
220,224
83.6%

Total assets
As of June 30, 2024
As of March 31, 2024

265,828
263,404

2. Dividends
Annual dividends per share (¥)
st1 quarter
Year ended March 31, 2024
Year ending March 31, 2025
Year ending
March 31, 2025 (forecast)nd2 quarter－－rdYear-end

3 quarter

Annual62.00－62.00124.0062.00－62.00124.003. Business Forecast for the Year Ending March 31, 2025 (April 1, 2024 to March 31, 2025)(¥ million)
RevenueFirst-half period
Full term

75,800154,000

Operating profit
%
3.4
3.9

15,00032,000%(28.2)(3.9)-1-Profit before tax

15,20032,500%(28.1)(3.3)

Net income
Basic earnings per
attributable toshare (¥)
owners of the parent
13,50029,000%(16.5)
12.2

200.44430.57

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, 2024:
70,251,484 shares
As of March 31, 2024:

70,251,484 shares

Number of shares of treasury stock
As of June 30, 2024:
As of March 31, 2024:

2,898,786 shares
2,898,726 shares

Average number of shares outstanding (total for the consolidated period)
As of June 30, 2024:
67,352,713 shares
As of June 30, 2023:

67,352,866 shares※Review of the attached condensed interim consolidated financial statements by certified public accountants or an audit
firm: Yes (voluntary)※Explanation of appropriate use of earnings forecasts and other special notes (Cautionary statement regarding forward-lookingstatements, etc.)
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, 2024
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, 2024

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

54,472
48,35737,428
10,6309,084
159,973

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

34,32429,4362,701
34,878
1,709
2,804
105,854
265,828

(Millions of yen)
As of March 31, 2024
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 June 30, 2024

24,706
372
1,720
3,594
6,941
37,336

21,649
269
1,385
896
8,626
32,826

232
1,152
4,090
58
5,533
42,870

248
1,238
3,993
58
5,539
38,365

5,174
4,445
198,260△2,48014,825220,224310
220,534
263,404

5,174
4,445
204,348△2,481
15,659227,147315
227,462
265,828

(2) Consolidated Statements of Income(Millions of yen)Three months ended
June 30, 2023

Three months ended
June 30, 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
Profit37,012
12,962
24,050
8,418
5,911
1,572
129
11,163298
21
11,4402,688
8,751

39,131
12,636
26,494
9,221
7,497
1,507
204
11,078363
3111,411
1,141
10,270

Profit attributable toOwners of parent
Non-controlling interests
Profit

8,749
2
8,751

10,264
5
10,270Earnings per share
Basic earnings per share

129.91152.40-5-(Consolidated Statements of Comprehensive Income)(Millions of yen)Three months ended
June 30, 2023
ProfitThree months ended
June 30, 2024
8,751

10,270

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

1,955

1,051

1,955

1,051

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

(2)

(2)
1,953
10,705(216)

(216)
834
11,104Comprehensive income attributable toOwners of parent
Non-controlling interests
Comprehensive income

10,703
2
10,705

11,0995
11,104-6-

(3) Consolidated Statements of Changes in Net Assets
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 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
Other
components ofequity
Total

Retainedearnings

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

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)202,489-7-30722309

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

Exchange
Financial assets
differences
measured at fair value
on translation
through otherof foreign
comprehensive income
operations
(616)
(2)
(2)
(619)

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

For the three-month period ended June 30,2024(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
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 ofequity
Total

Retainedearnings

Treasuryshares198,260
10,264
10,264(4,175)(4,175)204,348(2,480)(0)(0)(2,481)

Noncontrollinginterests

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

14,825834
834
15,659220,224
10,264834
11,099(0)(4,175)(4,176)
227,147

-8-

310
55315

220,534
10,270834
11,104(0)(4,175)(4,176)
227,462

Exchange
Financial assets
differences
measured at fair value
on translation
through otherof foreign
comprehensive income
operations
(488)
(216)
(216)
(704)

15,313
1,051
1,051
16,364

(4) Consolidated Statements of Cash Flow
(Millions of yen)Three months ended
June 30, 2023
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 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
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
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 cashequivalents
Net increase (decrease) in cash and cash equivalents
Cash and cash equivalents at beginning of period
Cash and cash equivalents at end of period

Three months ended
June 30, 2024

11,4401,236(298)
5(940)
31(899)948(4,425)
(204)
270
7,165
296
(5)
(6,930)526

11,411
1,464(363)
13(792)95(922)
1,797(3,388)(96)
1,677
10,896364(13)(4,243)7,004(45)30(1,661)(385)(0)
1(2,060)

(645)
630
(957)
(5,817)(0)1(6,788)

786

(410)
(0)
(3,918)(4,328)492(4,795)60,04755,251(3,621)58,09454,472(422)(0)(3,625)(4,047)-9-

Ｎｉｐｐｏｎ Ｓｈｉｎｙａｋｕ：Ｌｅａｄｉｎｇ Ｐｒｏｄｕｃｔｓ

August 7. 2024

Performance (consolidated)

Revenue
Operating profit
Profit before tax
Profit attributable toowners of parent(¥ million)
2024(IFRS)(estimated)

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

2021(IFRS)

2022(IFRS)

2023(IFRS)

114,716

116,637

121,859

137,484

144,175

148,255

154,000

20,644

21,66827,202

32,94830,04933,29532,00021,54022,442

27,60833,301

30,48933,61632,50016,302

16,866

19,54024,986

22,81225,851

29,000(¥ million)
Brand name

Active Ingredient

Indications

Launch Date

Viltepso(Japan)viltolarsen

Duchenne muscular
dystrophy

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

Sales 2024 (IFRS)Sales 2022
(IFRS)

Sales 2023
(IFRS)

Apr-JunApr-Sep(estimated)

Annual(estimated)

14,341

17,5305,450

10,30020,600(4,139)(4,407)1,175

2,3004,600(10,201)(13,123)

4,275

8,000

16,000Uptraviselexipag

pulmonary arterial
hypertension/
chronic thromboembolic
pulmonary hypertension

Nov-2016/
Aug-2021

10,543

12,918

3,855

7,600

15,400Vidazaazacitidine

myelodysplastic
syndrome/
acute myeloid leukemia

Mar-2011/
Mar-2021

15,951

10,383

1,462

2,600

4,800

Gazyvaobinutuzumab

CD20-positive follicularlymphoma/
CD20-positive chronic
lymphocytic leukemia

Aug-2018/
Dec-2022

4,904

4,695

1,254

2,500

5,100

Tramal, Onetram

tramadolhydrochloride

cancer pain, chronic pain

Sep-2010

5,3583,927

778

1,400

2,700

Defitelio

defibrotide sodium

sinusoidal obstruction
syndrome

Sep-2019

2,524

2,221

709

1,100

2,300

Cialistadalafil

erectile dysfunction

Jul-2009

2,938

2,499

647

1,400

2,700

Zalutiatadalafil

urinary disorder causedby benign prostatic
hyperplasia

Apr-2014

2,826

2,256

493

850

1,600

Adcircatadalafil

pulmonary arterial
hypertension

Dec-2009

2,649

2,255

480

900

1,700

Erizasdexamethasone
cipecilate

allergic rhinitis

Dec-2009

2,640

2,284

281

700

2,100

Profit in co-promotion

9,520

8,658

2,461

4,550

9,100Revenues from the licensing of industrial property rights

30,71440,304

10,77921,00042,100

Pharmaceuticals

121,988

125,105

33,73865,300132,500

Functional Food

22,18723,150

5,393

10,50021,500

Revenue

144,175

148,255

39,13175,800154,000- 10 -Ｎｉｐｐｏｎ Ｓｈｉｎｙａｋｕ：Ｒ＆Ｄ Pipeline List

August 7. 2024

＜Domestic＞
StageLaunch
Phase III

Code No.
(Generic name)
NS-065/NCNP-01(viltolarsen)

Therapeutic field

Indications

intractable diseases・orphan
Duchenne muscular dystrophy
diseasespatients with relapsed or refractorymantle cell lymphoma who are resistantor intolerant to other BTK inhibitors

OriginDevelopment

Co - development:
National Center of Neurology andPsychiatry

Nippon Shinyaku Co., Ltd.

Alliance agreement in Japan: Eli Lilly
Japan K.K.

Eli Lilly Japan K.K.

Preparation for launch

LY3527727(pirtobrutinib)

hematologic malignancies

NDA filing

NS-304(selexipag)

intractable diseases・orphan pediatric pulmonary arterial
diseases
hypertension

Nippon Shinyaku Co., Ltd.

Co - development:
Janssen Pharmaceutical K.K.

Phase III

ZX008
(fenfluraminehydrochloride)

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

Phase IIIGA101
(obinutuzumab)

intractable diseases・orphan
lupus nephritis
diseases

Licensed - in from
Chugai Pharmaceutical Co., Ltd.

Co - development:
Chugai Pharmaceutical Co., Ltd.

Phase IIIGA101
(obinutuzumab)

intractable diseases・orphan
pediatric nephrotic syndrome
diseases

Licensed - in from
Chugai Pharmaceutical Co., Ltd.

Co - development:
Chugai Pharmaceutical Co., Ltd.

Phase IIIGA101
(obinutuzumab)

intractable diseases・orphan
extra renal lupus
diseases

Licensed - in from
Chugai Pharmaceutical Co., Ltd.

Co - development:
Chugai Pharmaceutical Co., Ltd.

Phase III

LY3527727(pirtobrutinib)

hematologic malignancies

mantle cell lymphoma

Alliance agreement in Japan: Eli Lilly
Japan K.K.

Eli Lilly Japan K.K.

Phase III

LY3527727(pirtobrutinib)

hematologic malignancies

chronic lymphocytic leukemia

Alliance agreement in Japan: Eli Lilly
Japan K.K.

Eli Lilly Japan K.K.

Phase II

NS-304(selexipag)

cardiovasculararteriosclerosis obliterans

Nippon Shinyaku Co., Ltd.

Nippon Shinyaku Co., Ltd.

Phase II

NS-580gynecologyendometriosis

Nippon Shinyaku Co., Ltd.

Nippon Shinyaku Co., Ltd.

Phase II

NS-580urological diseases

chronic prostatitis / chronic pelvic
pain syndrome

Nippon Shinyaku Co., Ltd.

Nippon Shinyaku Co., Ltd.
Nippon Shinyaku Co., Ltd.

Phase II

NS-089/NCNP-02(brogidirsen)

intractable diseases・orphan
Duchenne muscular dystrophy
diseasesCo - development:
National Center of Neurology andPsychiatry

Phase II

NS-229intractable diseases・orphan eosinophilic granulomatosis withdiseases
polyangiitis

Nippon Shinyaku Co., Ltd.

Nippon Shinyaku Co., Ltd.

Phase I/II

NS-401(tagraxofusp)

Licensed - in fromThe Menarini Group

Nippon Shinyaku Co., Ltd.

Co - development:
National Center of Neurology andPsychiatry

Nippon Shinyaku Co., Ltd.

hematologic malignancies

blastic plasmacytoid dendritic cell
neoplasm

Preparation for Phase
I/II

NS-050/NCNP-03

intractable diseases・orphan
Duchenne muscular dystrophydiseases

Phase I

NS-917(radgocitabine)

hematologic malignancies

relapsed/refractory acute myeloid
leukemia

Licensed - in from
Delta-Fly Pharma, Inc.

Nippon Shinyaku Co., Ltd.

Phase I

NS-025

urological diseasesurological diseases

Nippon Shinyaku Co., Ltd.

Nippon Shinyaku Co., Ltd.

Phase I

NS-863

cardiovascularcardiovascular diseases

Nippon Shinyaku Co., Ltd.

Nippon Shinyaku Co., Ltd.

Indications

Origin＜Overseas＞
Stage

Code No.
(Generic name)

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

Development

US Launch
Phase III

NS-065/NCNP-01(viltolarsen)

intractable diseases・orphan
Duchenne muscular dystrophy
diseases

Phase IIICAP-1002(deramiocel)

intractable diseases・orphan
Duchenne muscular dystrophy
diseasesPhase II

NS-089/NCNP-02(brogidirsen)

intractable diseases・orphan
Duchenne muscular dystrophy
diseasesCo - development:
National Center of Neurology andPsychiatry

Nippon Shinyaku Co., Ltd.

Phase II

NS-229intractable diseases・orphan eosinophilic granulomatosis withdiseases
polyangiitis

Nippon Shinyaku Co., Ltd.

Nippon Shinyaku Co., Ltd.

intractable diseases・orphan
Duchenne muscular dystrophy
diseasesCo - development:
National Center of Neurology andPsychiatry

Nippon Shinyaku Co., Ltd.

Preparation for Phase
I/II

NS-050/NCNP-03- 11 -Nippon Shinyaku Co., Ltd.
Capricor Therapeutics, Inc.