KISSEI’s Company Profile

Updated in February 2020

 Corporate Profile

Chairman & CEO: Mutsuo Kanzawa

President & COO: Yoshio Furihata
Founded: August 9, 1946
Stock Exchange: The First Section of the Tokyo Stock Exchange
Headquarters: Matsumoto-city, Nagano-prefecture
Tokyo Main Offices: Nihonbashi and Koishikawa
Employees: 1,504
(as of March 2019) R&D: 292
Marketing : 835 (Medical Reps: 642)
Manufacturing: 136
Others: 241
Overseas Subsidiary: Kissei America Inc. (Fort Lee, NJ)

2
 KISSEI’s Product Launch History

In-licensed 2019 DARBEPOETIN α BS, renal anemia

2018 BEOVA®, overactive bladder
2017 RECTABUL®, ulcerative colitis
2015 P-TOL®, hyperphosphatemia
2014 SAVENE®, anthracycline extravasation
2011GLUBES®,
2010 EPOETIN α BS, renal anemia type 2 diabetes
2006 URIEF®, benign
2005 SALAGEN®, xerostomia prostatic hyperplasia
2004 GLUFAST®,
2000 ZOLADEX®, endometriosis type 2 diabetes
1999 RIZMON® TG, glaucoma 1995 RIZABEN® EYE DROPS,
allergic conjunctivitis
®
1992 DOMENAN®, bronchial asthma
1991 BEZATOL , hyperlipidemia
1988 XANBON®, cerebral circulation
1986 UTEMERIN®, premature labor
1982 RIZABEN®, allergic diseases
1961 GASCON®, anti-gas agent In-house
1946 Founded

3
 Operational Organization
◆ Sales Force: 10 Sales Branches
50 Offices
Headquarters
◆ Oversea Subsidiary:
Matsumoto Area Kissei America Inc.
◆ Headquarters (Fort Lee, NJ)
◆ Laboratories (3)
➢ Central Research Labs.
➢ Toxicological Labs. ◆ Joetsu Chemical Laboratory
➢ Pharmaceutical Labs.
Matsumoto Plant ◆ Manufacturing Site (2)
➢ Matsumoto and Shiojiri
Nihonbashi Office Koishikawa Office

Shiojiri Plant

◆ Tokyo Main Offices:

Nihonbashi, Koishikawa

4
Location of Kissei’s Laboratories

Mt. Jonen
Northern Alps
(Japanese Alps)

Toxicological
Labs.

Central Research Labs. &

Pharmaceutical Labs.

5
 Kissei’s Organization
Corporate Development
Research
Corporate Strategy
& Planning
Strategic Alliance

Clinical Development
Quality, Safety and Regulatory Affairs
Pharmaceutical Manufacturing

Chairman & President & Sales & Marketing

CEO COO Medical Affairs
Licensing
Business Development
Alliance Management
Intellectual Property & Global Marketing

Legal Affairs
Nutrition
Others

6
Kissei’s Areas of Strategic In-Licensing Focus

Urology

Nephrology

Gastrointestine
R&D and
Commercial Ophthalmology

Obstetrics & Gynecology

Other high unmet needs

including Orphan, Neurology, Hematology

Commercial Only Diabetes

7
 Financial Highlights in FY2018
(April 2018 to March 2019; Non-consolidated)
FY2018 Mil. JPY Mil. USD
Net Sales 61,520 559.3
Operating Income 5,487 49.9
Net Income 5,064 46.0
R&D Expenditure※ 15,711 142.8
% on Net Sales 25.5 % ※consolidated

Net Sales Operating Income Net Income R&D Expenditure R&D rate (% on Net Sales)
Net Sales (Mil. USD) Income (Mil. USD) Expenditure (Mil. USD) R&D rate (%)
600 120 160 35
500 100 140 30
120 25
400 80 100 20
300 60 80
60 15
200 40 10
40
100 20 20 5
0 0 0 0

Fiscal year ends March 31 of each year. @:¥110/$

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 Global Product (Urology)
• URIEF® (Silodosin) in-house
– MoA: Selective 1A adrenoceptor antagonist
• Dysuria associated with benign prostatic hyperplasia (2006)
• Additional dosage form: Orally disintegrating tablet (2016)
– Co-marketing with Daiichi-Sankyo Co., Ltd. in Japan
• Daiichi Sankyo Espha Co., Ltd. launched authorized generic (2019)
– Launched in over 50 countries
As of March 2019 Silodosin Partners
Licensee Territory Brand name
US, Canada &
Allergan RAPAFLO®
Latin America
Europe & UROREC®,
Recordati Middle East, SILODYX®,
Australia SILOSIN®
JW Pharma Korea THRUPAS®
Synmosa Taiwan URIEF®
:Launched Daiichi-
China URIEF®
:Approved Sankyo

:NDA Eisai
ASEAN &
URIEF®
India

9 9
 NEW Product (Urology)
• BEOVA® (Vibegron) in-licensed
– MoA: β3-adrenergic receptor agonist
• Overactive bladder (2018)
– Dosage form: Tablet
– Sublicensed from Kyorin Pharmaceutical Co., Ltd. 【Originator : MSD】
– Co-development and co-marketing with Kyorin Pharmaceutical Co., Ltd.
– Urovant Sciences Ltd. is developing in US and Europe for OAB.

10
 NEW Product (Renal・Dialysis)
⚫ P-TOL® (Sucrofferic Oxyhydroxide) in-licensed
– MoA: Phosphate binder in gastrointestinal tract
• Hyperphosphatemia in dialysis patients (2015)
– Dosage form: Chewable tablet
• Additional dosage form: Granules (2018)
– Licensed from Vifor Fresenius Medical Care Renal Pharma Ltd.
– Known as Velphoro® in Europe and US

Chewable tablet

The donut shape to be chewed easily and to avoid suffocation.

Granules

Micro-tablet-type granules(Φ2.3 mm), not to be stuck in dentures.

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 Development Pipeline 1
Therapeutic Product Code MoA/ Originator/ Available
Phase
Field Generic Name Indication Partner Territory
Genetically engineered Proaerolysin/
JP Sophiris/
PRX-302 Benign Prostatic Hyperplasia, -
Pre-IND Kissei
Prostate Cancer
Urology
Transient receptor potential cation channel
JP
KSP-0576 subfamily M member 8 (TRPM8) antagonist/ Kissei Global
Preclinical
Overactive bladder
JP Kappa opioid receptor agonist/ Cara/
MR13A9 -
Renal/ PII Uremic pruritus in dialysis Maruishi-Kissei
Dialysis JP Inhibitor of the complement C5a receptor/ ChemoCentryx/
Avacopan -
PIII ANCA-associated vasculitis VFMCRP/Kissei
US,EU PIIb
SGLT2 inhibitor/
(India
Type 2 diabetes Kissei/ Global
Launched)
Remogliflozin Avolynt (Global), (except
US Glenmark (India) India)
SGLT2 inhibitor/
Metabolism PII/III/IV
NASH
in Prep
KUX-1151 US PI
Inhibition of Xanthine Oxidase and URAT1/
& JP PIIa Kissei Global
Hyperuricemia, gout
KUX Back-Up (KUX-1151)
JP Oral GnRH antagonist/
Kissei
PII Endometriosis, Uterine fibroid
KLH-2109 US,EU Oral GnRH antagonist/
Ob/Gyn Asia
Linzagolix PIII Uterine fibroid Kissei/
US,EU Oral GnRH antagonist/ ObsEva (Global)
PIII Endometriosis 12
 Development Pipeline 2
Therapeutic Product Code MoA/ Originator/ Available
Phase
Field Generic Name Indication Partner Territory
Ophthal- JP IgE trapping Fc-fusion protein/
KCE-210 Kissei Global
mology Preclinical Allergic Conjunctival Diseases
AJM300 JP Oral α4 integlin antagonist/ EA/
-
Carotegrast Methyl PIII Ulcerative colitis EA-Kissei
GI
KWA-0711 JP SGLT1 inhibitor/
Kissei Global
Mizagliflozin PII Chronic constipation

KPS-0373 JP Thyrotropin-releasing hormone analogue/ Shionogi/

-
Rovatirelin PIII Spinocerebellar degeneration Kissei

JP Dopamine agonist/
Neurology KDT-3594 Kissei Global
PII Parkinson's disease

JP Oral CGRP receptor antagonist/

KCZ-1279 Kissei Global
Preclinical Migraine prophylaxis

JP PIII China
Spleen associated tyrosine kinase inhibitor/ Rigel/
Fostamatinib US Launch Korea
Immune Thrombocytopenia Kissei
EU Approved Taiwan
US,EU Selective β2 adrenoceptor agonist/
PII Acute exacerbation of asthma Kissei/
Others Bedradorine -
US Selective β2 adrenoceptor agonist/ MediciNova
PI COPD

JP Neurokinin 1 receptor antagonist/

KNV-0969 Kissei Global
Preclinical Chronic pruritus
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 Seeking Partners
Therapeutic Product Code MoA/ Originator/ Available
Phase
Field Generic Name Indication Development Territory
Transient receptor potential cation channel
JP
Urology KSP-0576 subfamily M member 8 (TRPM8) antagonist/ Kissei Global
Preclinical
Overactive bladder
US,EU PIIb
SGLT2 inhibitor/
(India Kissei/ Global
Type 2 diabetes
Remogliflozin Launched) Avolynt (Global), (except
US SGLT2 inhibitor/ Glenmark (India) India)
Metabolism
PII/III/IV in Prep NASH
KUX-1151 US PI
Inhibition of Xanthine Oxidase and URAT1/
& JP PIIa Kissei Global
Hyperuricemia, gout
KUX Back-Up (KUX-1151)
JP Oral GnRH antagonist/
Kissei
PII Endometriosis, Uterine fibroid
KLH-2109 US,EU Oral GnRH antagonist/
Ob/Gyn Asia
Linzagolix PIII Uterine fibroid Kissei/
US,EU Oral GnRH antagonist/ ObsEva (Global)
PIII Endometriosis
Ophthal- JP IgE trapping Fc-fusion protein/
KCE-210 Kissei Global
mology Preclinical Allergic Conjunctival Diseases
KWA-0711 JP SGLT1 inhibitor/
GI Kissei Global
Mizagliflozin PII Chronic constipation
JP Dopamine agonist/
KDT-3594 Kissei Global
PII Parkinson's disease
Neurology
JP Oral CGRP receptor antagonist/
KCZ-1279 Kissei Global
Preclinical Migraine prophylaxis
JP PIII China
Spleen associated tyrosine kinase inhibitor/ Rigel/
Fostamatinib US Launch Korea
Immune Thrombocytopenia Kissei
Others EU Approved Taiwan
JP Neurokinin 1 receptor antagonist/
KNV-0969 Kissei Global
Preclinical Chronic pruritus 14
 Kissei Partners

Partners of in-house products Partners of in-licensed products

P-TOL ®, Avacopan
RAPAFLO ® UROREC ®, SILODYX ® EPOETIN α BS
SILOSIN ® DARBEPOETIN α BS

ZOLADEX ®

FULSTAN ® FRAGMIN ®
THRUPAS ® URIEF ®,
GLUFAST ® GLUFAST ® URIEF ®

Wakamoto
RYSMON ® TG SAVENE ® AJM300, RECTABUL ®

URIEF ® GLUFAST ®

KPS-0373
BEOVA ®
GLUFAST ®

Maruishi
YS110 MR13A9 Fostamatinib PRX-302
Linzagolix Partners of other products

Remogliflozin Bedoradrine
MINIRIN MELT ® MARIZEV ®
15 15
 Kissei Pharmaceutical Co., Ltd.
Corporate Development, Business Development
1-8-9 Nihonbashi Muromachi, Chuo-Ku, Tokyo
103-0022, Japan
<Tel> +81-(0)3-3279-2307
<Fax> +81-(0)3-3279-2541
<Web> https://www.kissei.co.jp/e_contents/
Kissei License & Alliance Organization
Dr. K. Akiyama, Senior Director Dr. Y. Takehana, Managing Director

Business Development Corporate Development

Mr. T. Shimizu, Assistant Director Mr. K. Nakata, Director

Licensing Strategic Alliance

Ms. M. Okumura, Manager Dr. M. Hiratochi, Director
Mr. T. Terayama, Assistant Manager Mr. T. Yamato, Director
Ms. Y. Itakura , Section Leader Mr. Y. Shimizu, Director
Mr. Y. Todoroki Dr. O. Nakanishi, Assistant Manager

Alliance Management &

Global Marketing Kissei America Inc.
Mr. H. Ishibashi, Manager
Mr. Y. Kato, President
Mr. M. Tomae, Deputy Manager
Ms. M. Morikawa, Manager
Mr. N. Shiina, Section Leader
Ms. S. Furihata

17
 Proportions of Sales by Therapeutic Areas
in FY2018
Sales to Partners & Royalty
Silodosin, Mitiglinide, etc

11.0% Urology
Others URIEF®
SALAGEN® BEOVA®
RIZABEN®
XANBON® 30.1%
DOMENAN®, etc
23.4%
Ophthalmology
RIZABEN® EYE DROP 1.7%
RYSMON® TG
18.5%
Ob/Gyn Renal/Dialysis
12.7%
UTEMERIN® 2.6% P-TOL®
ZOLADEX® Metabolism EPOETIN α BS
GLUFAST® FRAGMIN®
GLUBES® FULSTAN®
BEZATOL®

18
 Net Sales of Kissei’s Main Products

◆ : In-house product Fiscal year ends March 31 of each year. @:¥110/$

◆ : In-licensed product FY2017 FY2018

Brand name Mil. JPY Mil. JPY Mil. USD Indication

◆ URIEF® 17,235 17,810 161.9 Benign prostatic hyperplasia

◆ EPOETIN α BS 6,093 6,015 54.7 Renal anemia

◆ P-TOL® 4,274 4,801 43.6 Hyperphosphatemia

◆ GLUBES® 4,477 4,428 40.3 Type II diabetes

◆ BEZATOL® 2,564 1,709 15.5 Hyperlipidemia

◆ GLUFAST® 2,762 1,678 15.3 Type II diabetes

◆ SALAGEN® 1,561 1,617 14.7 Xerostomia

◆ BEOVA® 706 6.4 Overactive bladder

◆ RECTABUL® 228 663 6.0 Ulcerative colitis

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 Global Product (Metabolism)
• GLUFAST® (Mitiglinide) in-house
– MoA: Rapid-acting insulin secretagogue
• Type II diabetes
• Monotherapy (2004)
• α-GI combination use (2007)
• TZD combination use (2009)
• BG / DPP-4i combination use (2013)
• Additional dosage form: Orally disintegrating tablet (2016)
– Co-marketing with Takeda Pharmaceutical Co., Ltd.
– Launched in Asian countries
Mitiglinide Partners
Licensee Territory
JW Pharma Korea

Orient EuroPharma Hong Kong & Taiwan

Eisai China & ASEAN

20
 NEW Product (GI)
• RECTABUL® (Budesonide Rectal Foam) in-licensed
– MoA: Glucocorticoid activity
• Ulcerative colitis (2017)
– Dosage form: Rectal foam
– Sublicensed from EA Pharma Co., Ltd. 【Originator : Dr. Falk Pharma】
– Co-marketing with EA Pharma Co., Ltd.
– Known as Budenofalk® /Ulceris® rectal foam in Europe and US

21
 Products 1
Therapeutic Brand Name Sales MoA/
Licensor
Field Generic name (Mil. US$) Indication
URIEF® Selective α1A adrenoceptor antagonist/
161.9 In-house
Silodosin Benign prostatic hyperplasia (2006)
BEOVA® Selective β3 adrenoceptor agonist/ MSD/
Urology 6.4
Vibegron Overactive bladder (2018) Kyorin-Kissei
MINIRIN MELT® Vasopressin receptor agonist/ Ferring
-
Desmopressin Acetate Nocturia due to nocturnal polyuria (2019) (Co-Promotion)
Recombinant human erythropoietin/
EPOETIN α Biosimilar 54.7 JCR
Renal anemia on dialysis (2010)
DARBEPOETIN α Long-acting ESA/
- JCR
Biosimilar Renal anemia (2019)
P-TOL®
Phosphate binder in gastrointestinal tract/
Renal/ Sucrofferic 43.6 VFMCRP
Hyperphosphatemia in dialysis patients (2015)
Dialysis Oxyhydroxide
FULSTAN® Active vitamin D3/ Sumitomo
3.8
Falecalcitriol Secondary hyperparathyroidism (2001) Dainippon
Anticoagulant (low molecular weight heparin)/
FRAGMIN® Kabi Vitrum
1.3 Hemodialysis (1992)
Dalteparin (Pfizer)
Disseminated intravascular coagulation (DIC) (1994)
GLUBES® Mitiglinide & Voglibose combination product/
40.3 In-house
Mitiglinide + Voglibose Type II diabetes (2011）
BEZATOL® PPAR agonist/
15.5 Roche
Bezafibrate Hyperlipidemia (1991)
Metabolism
GLUFAST® Rapid-acting insulin secretagogue/
15.3 In-house
Mitiglinide Type II diabetes (2004)
MARIZEV® DPP4 inhibitor/
- MSD※
Omarigliptin Type 2 diabetes (2015)
※Transfer of distribution operation from April 2020.

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 Products 2
Therapeutic Brand Name Sales MoA/
Licensor
Field Generic name (Mil. US$) Indication
UTEMERIN® β2 adrenoceptor agonist/ Solvay
10.4
Ritodorine Premature labor (1986) (Mylan)
Ob/Gyn
ZOLADEX® GnRH agonist/
4.2 AstraZeneca
Goserelin Endometriosis (2000)
RIZABEN® EYE DROPS Inhibition of chemical mediators release from mast cells/
7.6 In-house
Ophthal- Tranilast Allergic conjunctivitis (1995)
mology RYSMON® TG β adrenoceptor antagonist/
2.0 Wakamoto
Timolol Glaucoma (1999), Ocular hypertension (1999)
RECTABUL® Budesonide rectal foam/ Dr. Falk/
GI 6.0
Budesonide Ulcerative colitis (2017) EA-Kissei
Muscarinic receptor (M3) agonist/
Xerostomia (dry mouth)
SALAGEN® MGI
14.7 Radiation therapy (head and neck cancer) (2005)
Pilocarpine (Eisai)
Sjögren syndrome (2007)
Additional dosage form: Granule form (2014)
Inhibition of thromboxane A2 synthetase/
XANBON®
3.7 Vasospasm after subarachnoid hemorrhage surgery (1988) In-house
Ozagrel Na
Acute cerebral thrombosis (1992)
Inhibition of chemical mediators release from mast cells
Others
Inhibition of synthesis of collagen in fibroblasts/
RIZABEN® Bronchial asthma (1982)
3.3 In-house
Tranilast Allergic rhinitis (1985)
Atopic dermatitis (1985)
Keloid, Hypertrophic scar (1993)
DOMENAN® Inhibition of thromboxane A2 synthetase
0.8 In-house
Ozagrel HCl Bronchial asthma (1992)
SAVENE® Catalytic inhibitor of topoisomerase II/
0.7 Clinigen
Dexrazoxane Antidote for anthracycline extravasation (2014) 23