Outline of Consolidated Financial Results
for the Year Ended March 31, 2020
May 18, 2020
NIPPON SHINYAKU CO., LTD.

FY2019 Main Topics
2019
4/1

・Start of 6th Five-Year Medium-term Management Plan

5/22

・Launch of Erleada for the treatment of prostate cancer (co-promotion with Janssen Pharmaceutical K.K.)

8/22

・NS-065/NCNP-01 for the treatment of Duchenne muscular dystrophy, granted Orphan Drug Designation

9/4

・Launch of Defitelio for the treatment of sinusoidal obstruction syndrome

10/1

・Nippon Shinyaku 100th anniversary

11/6

・Designation of NS-065/NCNP-01 Subjected to Conditional Early Approval System

2020
2/7

・NDA Accepted for Filing by the FDA for NS-065/NCNP-01

2/7

・New co-promotion agreement for Zytiga for the treatment of prostate cancer

3/25

・Marketing authorization in Japan for NS-065/NCNP-01
2

FY2019 Summary◆ Net sales： 116,637 million yen （+1.7%）◆ Operating profit：

21,668 million yen （+5.0%）◆ Ordinary profit：

22,442 million yen （+4.2%）

Profit attributable：

16,866 million yen （+3.5%）◆ to owners of parent（million yen）

3

Segmental Review - Pharmaceuticals 100,223＋1,273
Revenues from the licensing ofindustrial property rights

-760
+906
101,643（Million yen）
Ethical drugs
Revenues from the licensing ofindustrial property rights

Profit in co-promotion
Net sales

FY2018+1,419YoY Change

FY2019Results

Ratio

Results

Ratio

Amt

%

78,54478.4%

79,81878.5%+1,273+1.6%

16,621

16.6%

15,860

15.6%

-760

-4.6%

5,057

5.0%

5,963

5.9%

+906

+17.9%

100,223100.0%

101,643100.0%+1,419+1.4%

Net sales increased by 1.4% due to growth of new products and profit in co-promotion.
4

Three Main Fields of Focus(million yen)

PAH

Hematology
YoY Change+14.3%

UrologyYoY Change+29.0%
24,00024,00012,00016,00016,000

6,000

8,000

8,000

18,0000

0FY2017FY2018FY20190
FY2017

Uptravi (domestic)

VidazaOpsumit (Profit in co-promotion)

GazyvaAdcircaYoY Change+3.8%

FY2018

Defitelio
Others

FY2019FY2017FY2018FY2019

Zalutia
CialisOthers

New products sales from our focus fields increased.
5

Segmental Review - Functional Food 14,492
+176
+165
+83
+75
+501

14,994（Million yen）

FY2018FY2019YoY Change

Results

Ratio

Results

Ratio

Amt

%

Protein preparations

9,554

65.9%

9,731

64.9%

+176

+1.9%

Preservatives

2,310

15.9%

2,475

16.5%

+165

+7.1%

Health food ingredients

1,196

8.3%

1,280

8.5%

+83

+7.0%

Others

1,431

9.9%

1,506

10.1%

+75

+5.3%

Net sales

14,492100.0%

14,994100.0%

+501

+3.5%

Net sales increased by 3.5% due to growth of protein preparations and preservatives.
6Operating profit
20,644+1,419+501-2,203-1,400+2,707+1,023

21,668（Million yen）

FY2018FY2019YoY Change

Results

Ratio

Results

Ratio

Amt

%

114,716100.0%

116,637

100.0%+1,921+1.7%(Pharmaceuticals)(100,223)(87.4%)(101,643)(87.1%)(+1,419)(+1.4%)(Functional Food)(14,492)(12.6%)(14,994)(12.9%)(+501)(+3.5%)

Operating expenses

94,071

82.0%

94,969

81.4%

+897

+1.0%

Cost of sales

50,952

44.4%

53,15545.6%+2,203+4.3%

SG&A expenses

26,41823.0%

27,81923.8%+1,400+5.3%

R&D expenses

16,701

14.6%

13,99412.0%-2,707-16.2%

Operating profit

20,64418.0%

21,66818.6%+1,023+5.0%

Net sales

7Profit attributable to owners of parent
16,302＋1,023
＋163

-284
-337
+564

16,866（Million yen）

FY2018FY2019Results

Results

YoY Change
Amt%

Operating profit

20,644

21,668+1,023+5.0%

Non-operating income

1,435

1,599

+163

+11.4%

Non-operating expenses

539

824

+284

+52.8%

Ordinary profit

21,54022,442

+901

+4.2%

Income taxes, etc

5,237

5,575

+337

+6.5%

16,302

16,866

+564

+3.5%

Profit attributableto owners of parent

8

Business Forecast for FY2020
FY2019FY2020Results

Forecast

Net sales

116,637

Operating profit
Ordinary profit（Million yen）

Profit attributableto owners of parent

YoY Change
Amt%

126,000+9,363+8.0%

21,66825,000+3,332+15.4%

22,44225,500+3,058+13.6%

16,86619,000+2,134+12.6%

We look for net sales, operating profit, ordinary profit andprofit attributable to owners of parent to increase year on year.

9

Segmental Forecast - Pharmaceuticals （Million yen）
Ethical drugs
Revenues from the licensing ofindustrial property rights

Profit in co-promotion
Net sales

FY2019Results

FY2020Ratio

Forecast

YoY Change
Ratio

Amt

%

79,81878.5%

82,70074.7%+2,882+3.6%

15,86015.6%

19,70017.8%+3,840+24.2%

5,963

5.9%

8,300

7.5%

+2,337+39.2%

101,643100.0%

110,700

100.0%+9,057+8.9%

Royalty revenue from Uptravi’s overseas sales, profit in co-promotion,and launch of Viltepso for the treatment of Duchenne muscular
dystrophy will increase our net sales.

10Segmental Forecast - Functional Food -（Million yen）

FY2019Results

FY2020Ratio

Forecast

YoY Change
Ratio

Amt

%

Protein preparations

9,731

64.9%

9,680

63.3%

-51

-0.5%

Preservatives

2,475

16.5%

2,600

17.0%

+125

+5.0%

Health food ingredients

1,280

8.5%

1,300

8.5%

+20

+1.5%

Others

1,506

10.1%

1,720

11.2%

+214

+14.1%Net sales

14,994100.0%

15,300100.0%

+306

+2.0%

We will enhance our research and development toward new
products and continue to launch highly valued products withmarket needs to increase our net sales.

11Consolidated Statements of Income (Forecast)(Million yen）

FY2019FY2020YoY Change

Results

Ratio

Forecast

Ratio

Amt

%

116,637

100.0%

126,000

100.0%+9,363+8.0%(Pharmaceuticals)(101,643)(87.1%)(110,700)(87.9%)(+9,057)(+8.9%)(Functional Food)(14,994)(12.9%)(15,300)(12.1%)(+306)(+2.0%)

Cost of sales

53,15545.6%

52,600

41.7%

-555

-1.0%

SG&A expenses

27,81923.9%30,00023.8%+2,181+7.8%

R&D expenses

13,99412.0%

18,40014.6%+4,406+31.5%

Operating profit

21,66818.6%

25,00019.8%+3,332+15.4%

Non-operating income

1,599

1.4%

1,200

1.0%

-399

-25.0%

Non-operating expenses

824

0.7%

700

0.6%

-124

-15.1%

Ordinary profit

22,44219.2%

25,50020.2%+3,058+13.6%

Income taxes, etc

5,575

4.8%

6,500

5.2%

+925

+16.6%

16,86614.5%

19,00015.1%+2,134+12.6%Net sales

Profit attributableto owners of parent

12Dividends Forecast
FY2019FY2020Interim¥43¥49

Annual

¥86

¥99

ＥＰＳ

¥250.42¥282.09

Dividends payout ratio

34.3 ％

35.1 ％

Dividends per share

(Yen)

99

100

86
80

70

AnnualInterim

60

48

52

2016

2017

40
20
0

2018

2019

2020
13

Status of Product Pipeline

R&D Compounds (Domestic)
Code No.
(Generic name)<Origin>Application
type

Preparation for

Indications

development

NS-065/NCNP-01(viltolarsen)

PI

PII

PIII

PI

NME

Duchenne muscular dystrophy

NME

Iron deficiency anemia

Preparation forlaunching

PII
PIII
in progress<in-house>
NS-32(ferric derisomaltose)<in-license>
ZX008<in-license>

NME

Dravet syndrome
Lennox-Gastaut syndrome
Chronic thromboembolic pulmonary hypertension

NS-304(selexipag)<in-house>New
indication

Arteriosclerosis obliterans
Lumbar spinal stenosis

NS-580<in-house>
NS-17(azacitidine)<in-license>
NS-87<in-license>
NS-917<in-license>

NME
New
indication
New
combination
NME

PIII
PIII

Endometriosis

Acute myeloid leukemia

Secondary acute myeloid leukemia
Relapsed/refractory acute myeloid leukemia：Changes from 3rd quarter 201915

R&D Compounds (Overseas)
Code No.
(Generic name)<Origin>prulifloxacin<in-house>

Application
type

Indications

NME

Bacterial infections

NME

Duchenne muscular dystrophy

Preparation fordevelopment

PI

PII

PIII

NDA filing

NS-065/NCNP-01(viltolarsen)<in-house>
NS-304(selexipag)<in-house>
NS-018(ilginatinib)

New
indication

NME

PIII
in progress

Chronic thromboembolic pulmonary hypertension

Myelofibrosis<in-house>

16NS-018 Development Strategy (1)[Challenge for current MF treatment]
Because MF patients whose platelet count is going
below 50,000/mL during a treatment with JAK inhibitors,
can not continue the treatment, it is difficult for them toobtain QOL improvement and their physical condition
becomes severe.
[Development strategy for next study]
In next study, a dosage is increased to 300mg BID(600mg/day) from 300mgQD (300mg/day) and a safety
and efficacy is assessed in naïve or JAK inhibitor treated
MF patients whose platelet count is below 50,000/mL

17

NS-018 Development Strategy (2)Summary of study design
Item
Target population

Arm

ContentNaïve or JAK inhibitor treated MF patients
whose platelet count is below 50,000/mL

Experimental

NS-018 (300mg BID)

Comparator

Best Available Therapy(exclude JAK inhibitors)

Estimated enrollment

94 patients in total

Treatment period

24 weeks
A proportion of patients achieving a >35%
spleen volume reduction (SVR) at Week
Improvement of Total Symptom Score(TSS)

Primary Endpoint
Secondary Endpoint

18

Efforts against
novel coronavirus infection

Efforts against novel coronavirus infection－Nucleic acid drugs (1)－The novel coronavirus is a long-chain RNA
virus that mutates easily.
The study of nucleic acid drugs will bestarted with the aim of making them
(1)widely applicable to viral infections ofmutant coronavirus as well as the novel
coronavirus itself and(2)long-lived antiviral drugs that can beapplied to the past SARS and MERS as well
as novel coronavirus infections that will
emerge in the future.
20

Efforts against novel coronavirus infection－Nucleic acid drugs (2)－Small-molecule drugs：Potential short-term effects can be
expected from drug repositioning. The regions of viralproteins to which small molecules can bind are limited. Even
if an effective small-molecule drug is found, the emergenceof a virus with a mutated binding region would render the
drug ineffective.
Vaccines target the surface proteins of viruses and have
similar limitations to small-molecule drugs. Even if an
effective vaccine is found, the emergence of a virus with amutated binding region would render the vaccine ineffective.
Nucleic acid drugs can target the entire viral genome
because they interact directly with the viral genome. They
can target invariant regions essential for viral replication.
21

Efforts against novel coronavirus infection－Nucleic acid drugs (3)－The types and structures of nucleic acids, such as long-chain RNA,
antisense nucleic acids (morpholino nucleic acids), and DNA enzymes,
will be studied to select the nucleic acids that effectively kill the novel
coronavirus.
The figure shows an example of the application of state-of-the-art long-chain RNA.

Long-chain RNAs are cleaved within the cell to produce several
siRNAs targeting multiple sites on the viral RNA, killing all of thenovel coronavirus.
22Efforts against novel coronavirus infection－Repositioning (1)－・In a sudden exacerbation of symptoms caused by thenovel coronavirus, the hyperreactivity of the immune
system (cytokine storm) is closely involved.
If this could be controlled, severe respiratory failure
could be prevented.

・If intracellular signaling mediated by JAK or IL-6 could
be inhibited, the cytokine storm could be suppressed.
Clinical trials of JAK inhibitors or anti-IL-6 receptor
antibodies from other companies have begun.

23

Efforts against novel coronavirus infection－Repositioning (2)－・NS-018, which is in clinical trial, and another drug in
preparation for clinical trial are JAK inhibitors withexcellent subtype selectivity and safety.
They are under consideration for reprofiling as
treatments for severe pneumonia and acute respiratory
distress syndrome (ARDS) caused by novel coronavirus
infection.
・In addition, repositioning of Uptravi, a treatment for
pulmonary arterial hypertension, is underconsideration for thrombosis caused by novel
coronavirus infection.
24

Reference Materials

Impact due to novel coronavirus infection (1)Business performance In order to stop the pandemic, people
are resisting to consult a doctor.
However, there is little impact toward
our focus fields such as Hematology
and PAH which need medical
treatment at all times.
 At this time, there is little impact
toward our business performance.
However, we can not confirm what
will happen when the virus
continues to last.

・Any new updates will be announced
immediately in the next following
quarter.

Research and Development
Domestic There is little impact toward our
research and development. Patient
enrollment for our main clinical trials
has been almost completed.

Overseas Our phase 3 trial for NS-065 has justbegun. At this moment, there is no
impact.

・Ensuring safety of patients andmedical institutions will always be ourfirst priority.

26

Impact due to novel coronavirus infection (2)Supply chain
Raw materials
 We are able to supply our raw
materials without any problems.
There is no impact toward ourmanufacturing plan.

Employee
Manufacturing base
 Our manufacturing bases are working
as usual.
 Our workers go through measurementof body temperature and arecompletely sanitized by alcohol.

Stock status
 Medical supplies with high medical
needs are stably supplied.
(corresponding to BCP) Our products have certain levels of
supply which has no problem instable supply.

Sales activity
 Most of our medical representatives
are working home.
 Flextime system, and staggered
working hours.
 Communication using cellphones,
emails and providing information
through the internet.

Headquarter Most of employees are working home.
 Flextime system, and staggered
working hours.
 Recommending web conferences.
27

Consolidated Statements of Income(Million yen）

FY2018FY2019YoY change

Results

Ratio

Results

Ratio

Amt

%

114,716100.0%

116,637

100.0%+1,921+1.7%(Pharmaceuticals)(100,223)(87.4%)(101,643)(87.1%)(+1,419)(+1.4%)(Functional Food)(14,492)(12.6%)(14,994)(12.9%)(+501)(+3.5%)

Cost of sales

50,952

44.4%

53,15545.6%+2,203+4.3%

SG&A expenses

26,41822.9%

27,81923.8%+1,400+5.3%

R&D expenses

16,701

14.6%

13,99412.0%-2,707-16.2%

Operating profit

20,64418.0%

21,66818.6%+1,023+5.0%

Non-operating income

1,435

1.3%

1,599

1.4%

+163

+11.4%

Non-operating expenses

539

0.6%

824

0.7%

+284

+52.8%

Ordinary profit

21,54018.8%

22,442

19.2%

+901

+4.2%

Income taxes, etc

5,237

4.6%

5,575

4.8%

+337

+6.5%

16,302

14.2%

16,866

14.5%

+564

+3.5%

Net sales

Profit attributableto owners of parent

28

Consolidated Balance Sheet
End of

End ofYoY Change

End of

End ofYoY Change

FY2018FY2019Amt

FY2018FY2019Amt（Million yen）

Assets168,763

175,017+6,254Current assets

110,720

121,925+11,204

Fixed assets

58,04253,091-4,950Liabilities

33,572

29,256-4,316

Current liabilities

25,406

24,965-441

Long-term liabilities

8,165

4,290

-3,875

135,190

145,760+10,570

168,763

175,017+6,254

Net assets
Total assets

168,763

175,017+6,254

Total liabilities
and net assets＝Liabilities and Net assets＝＝Assets＝Cash and deposits+4,485

Notes and accounts payable+3,227

Notes and accounts receivable-5,034

Accounts payable-1,718

Income taxes payable-1,515Net defined benefit liability-3,886Inventories
Investment securities
Deferred tax asset+10,521-4,550-855

Retained earnings+11,20929

Consolidated Statements of Cash Flows（Million yen）

FY2018FY2019YoY Change

Results

Results

Amt

Operating activities

15,31012,737-2,572

Investing activities

511-2,339-2,851

Financing activities-3,708-5,660-1,951

39,632

44,298+4,665

Cash and cash equivalents
at end of year

+ 12,737+ 15,310+ 511-2,339- 3,708
39,632- 5,660
44,29827,51030

NS-065/NCNP-01 (viltolarsen)- Treatment for Duchenne muscular dystrophy -Development Phase

・Japan: Preparation for launching・USA : NDA filing・global PIII

OriginCo-development: National Center of Neurology and Psychiatry

Development

Nippon Shinyaku

Mechanism of action

Exon 53 Skipping

Indication

Duchenne muscular dystrophy

Dosage form

Injection

Feature・Improvement in symptoms and prevention of the diseaseprogression by recovery of dystrophin protein expression・Morpholino based oligonucleotide with possible high safety profileand maximized activity

31

NS-32 (ferric derisomaltose)- Treatment for iron deficiency anemia Development Phase

Japan: PIII

Origin[Dec. 2016]
Licensed-in from: Pharmacosmos A/SDevelopment

Nippon Shinyaku

Mechanism of action

Iron

Indication

Iron deficiency anemia

Dosage form

IV bolus injection or IV drip infusion

Feature・Can be administered in high doses allowing full iron correctionin the majority of patients・Good safety profile with no dose dependent ADRs
・Minimal potential toxicity from release of labile iron due to tightiron binding in a matrix structure of interchanging isomaltosideand iron・No profound hypophosphatemia32

ZX008- Treatment for rare intractable epilepsy Development Phase

Japan: PIII

Origin[March. 2019]
Commercial rights from: Zogenix, Inc.

Development

Zogenix, inc

Mechanism of action

Serotonin agonist

Indication

Dravet syndrome and Lennox-Gastaut syndrome

Dosage form

Oral liquid agent

Feature・Effective for Dravet syndrome and Lennox-Gastaut syndrome
patients refractory to existing treatment options
・ZX008 can be used in combination with other drugs, asstandard of care for intractable epilepsy is based on
combination therapy.
33

NS-304 (selexipag)- Treatment for pulmonary hypertension, arteriosclerosis obliterans, lumbar spinal stenosis -Development Phase<CTEPH> Japan: PIII
Overseas: PIII
<ASO>
Japan: PIIb
<LSS>Japan: PIIa

OriginNippon Shinyaku

Development

・[Apr. 2008] Licensed-out to (outside Japan):
Actelion Pharmaceuticals Ltd. (Switzerland)
・Co-development in Japan:
Actelion Pharmaceuticals Japan Ltd. (CTEPH)
・Overseas: Johnson & Johnson (CTEPH)
・Nippon Shinyaku (ASO)
・Nippon Shinyaku (LSS)

Mechanism of action

Selective IP receptor agonist

Indication

・Chronic thromboembolic pulmonary hypertension (CTEPH)
・Arteriosclerosis obliterans (ASO)
・Lumbar spinal stenosis (LSS)

Dosage form

TabletFeatureLong-acting oral drug34

NS-580- Treatment for endometriosis Development Phase

Japan: PIIa

OriginNippon Shinyaku

Development

Nippon Shinyaku

Mechanism of action

Inhibition of membrane-associated prostaglandin E synthase-1

Indication

Endometriosis

Dosage form

Oral agent

FeatureTreatment for endometriosis without hormonal effect and withpossible analgesic potency35

NS-17 (azacitidine)- Treatment for acute myeloid leukemia Development Phase

Japan: PII

Origin[Oct. 2006]
Licensed-in from: Celgene Corporation

Development

Nippon Shinyaku

Mechanism of action

Inhibition of DNA methylation, Cytotoxic effects

Indication

Acute myeloid leukemia

Dosage form

Injection

Feature・Standard Treatment for acute myeloid leukemia thatineligible for intensive chemotherapy
・Improvement for life prognosis36

NS-87- Treatment for secondary acute myeloid leukemia -Development Phase

Japan: PI/II

Origin[Mar. 2017]
Licensed-in from: Jazz Pharmaceuticals

Development

Nippon Shinyaku

Mechanism of action

Liposomal combination of cytrabine and daunorubicin

Indication

Secondary acute myeloid leukemia (secondary AML)

Dosage form

Injection

Feature・NS-87 is the first therapy for the treatment of secondary
AML in Japan・The enhancement of antitumor activity and reducing adverse
events are expected by NS-87 accumulated in bone marrow.

37

NS-917- Treatment for relapsed or refractory acute myeloid leukemia -Development Phase

Japan: Preparation for Clinical Development

Origin[Mar. 2017]
Licensed-in from: Delta-Fly Pharma, Inc.

Development

Nippon Shinyaku

Mechanism of action

DNA strand-break by incorporating itself into DNA

Indication

Relapsed or refractory (r/r) acute myeloid leukemia (AML)

Dosage form

Injection

Feature・Significant anti-leukemic activity with unique mechanism ofaction from other nucleoside analogs at low dose continuous
infusion・Tolerable safety profile available to elderly patients with r/r
AML

38

Prulifloxacin- Quinolone antibacterial Japan
Licensee・Meiji Seika Pharma Co., Ltd.

Development phase・Launch (Dec. 2002) / Sword® Tablets

Overseas
LicenseeDevelopment phase

・Angelini (Italy)・Approval (Sep. 2004)
・Launch in Italy (Nov. 2004)
・Approval in European countries (Apr. 2005)

・Lee’s Pharmaceutical Holdings Ltd. (Hong Kong)

・Launch in Hong Kong (Nov. 2012)
・NDA filing in China

・Algorithm (Lebanon)

・Launch in Lebanon (Jan. 2012)39

NS-018 (ilginatinib)- Treatment for myelofibrosis Development Phase

Overseas (USA): PI/II

OriginNippon Shinyaku

Development

Nippon Shinyaku

Mechanism of action

JAK2 inhibitor

Indication

Myelofibrosis

Dosage form

TabletFeature・Potent and highly selective JAK2 inhibitor
・High efficacy and safety are expected for Myelofiblosis (MF)patients with low platelet count, for whom QOL improvement
can’t be obtained because no treatment is available

40Safe Harbor Statement• Materials and information provided during this presentation may contain so-called “forward-looking
statements.” These statements are based on current expectations, forecasts and assumptions thatare subject to risks and uncertainties which could cause actual outcomes and results to differ materiallyfrom these statements.
• Risks and uncertainties include general industry and market conditions, and general domestic andinternational economic conditions such as interest rate and currency exchange fluctuations. Risks anduncertainties particularly apply with respect to product-related forward-looking statements. Product risks
and uncertainties include, but are not limited to, technological advances and patents attained bycompetitors; challenges inherent in new product development, including completion or failure of clinical
trials; claims and concerns about product safety and efficacy; regulatory agency’s examination, obtaining
regulatory approvals; domestic and foreign social security reforms; trends toward healthcare cost
containment; and governmental laws and regulations affecting domestic and foreign operations.

• Also, for products that are approved, there are manufacturing and marketing risks and uncertainties, which
include, but are not limited to, inability to build production capacity to meet demand, unavailability of raw
materials, and competition with others.
• The Company disclaims any intention or obligation to update or revise any forward-looking statements
whether as a result of new information, future events or otherwise.
• This English presentation was translated from the original Japanese version.
In the event of any inconsistency between the statements in the two versions, the statements in theJapanese version shall prevail.