Interim Term Financial Results Ended
September 2019

November 8 , 2019
KYORIN Holdings, Inc.
President Yutaka OgiharaOutline of Consolidated Financial Results
・Trends of mainstay products

Consolidated Financial Results and Forecast
Status of Development PipelineInitiatives toward realization of
the long-term vision “HOPE 100”1Outline of Consolidated Financial Results2Outline of Consolidated Financial Results for theInterim Term Ended September 2019

（unit : ¥billion）

Change(forecast)

Sep/18Sep/19ChangeNet Sales

50.4

48.3

－2.1

－4.1

－3.8

Operating
Income

2.9

0.8

－2.1

－72.5

－1.5

Ordinary Income

3.2

1.1

－2.1

－66.2

－1.4

Net Income

2.2

0.8

－1.4

－62.4

－1.1

Change(%)

Announced on
May 13, 2019

We released a revision to our second-quarter financial results forecast on November 5, 2019 but thesecomparisons with the forecast show differences from the forecast announced on May 13, 2019.
3

Segment Sales and Breakdown of Gain and Loss

Sep/18（unit : ¥billion）

Sep/19Change(%)

ChangeChange(forecast)
Announced on
May 13, 2019

50.4

48.3

－2.1

－4.1

－3.8

47.6

45.5

－2.1

－4.4

－3.6

34.0

31.3

－2.7

－7.9

－2.5

33.4

30.9

－2.5

－7.4

－2.5

0.6

0.4

－0.2

－35.5

0

13.6

14.2

＋0.6

＋4.5

－1.1

2.8

2.8

0

＋0.5

－0.1

Cost of Sales

23.8

23.8

0

0

－

SG&A

23.7

23.8

＋0.１

＋0.1

－

Operating Income

2.9

0.8

－2.1

－72.5

－1.5

Ordinary Income

3.2

1.1

－2.1

－66.2

－1.4

Net Income

2.2

0.8

－1.4

－62.4

－1.1

Net Sales

Ethical drugs
business

Sales ofnew
ethicaldrugs
Generic
drugs

Healthcare BusinessJapan
Overseas

We released a revision to our second-quarter financial results forecast on November 5, 2019 but thesecomparisons with the forecast show differences from the forecast announced on May 13, 2019.
4

Highlights of Business Performance:①Net sales【 Net Sales ￥－2.1bin 】（Units: ¥billion）

New ethical drugs(Japan)￥－2.5bin

60

50.4
50

2.8

40

13.6

48.3
2.8

Ethical drugs
business

0.4

33.4

・Decrease of Gatifloxacin sales
Ethical drugs
business

47.6
20

New ethical drugs(overseas)￥－0.2bin

14.2

0.6
30

・Growth in Flutiform, Beova andNasonex sales
・Influence from the suspended supplyof DESALEX
・Decreased in prescriptions of longlisted drugs.

45.5
30.9

Generic drugs￥＋0.6bin・Increase of MONTELKAST AG and
MOMETASONE AG sales
・ Increase in sales of generic drugs
released in fiscal 201810

Healthcare Business￥±0・Growth of RUBYSTA

0
18年3月期
Sep/2018

第2四半期

19年3月期
Sep/2019

第2四半期

5

Highlights of Business Performance : ②Operating Income（Units: ¥billion）
3【 Operating Income－￥2.1bin 】

2.5

Gross Profit decreased

2

1.5

Net Sales decreased ¥2.1billion year on year.
Cost of sales ratio increased 2.0%.
・Product mix
・Fall in lump-sum revenue

－2.1

2.9
R&D expenses increased

0.8

1

+0.2

■￥5.0bin （Sep/2018）⇒￥5.2bin （Sep/2019）

－0.1

0.5

SG&A (exclude R&D) Expenses
decreased
・Decrease of Selling costs.

0￥18.7bin （Sep/2018）⇒￥18.6bin （Sep/2019）

Operating
IncomeSep/2018

Gross Profit

R&D
expenses

SG&A
Operating(exclude R&D)
IncomeExpenses

Sep/2019
6

Highlights of Business Performance：③Change (forecast)
Change(forecast)

Change(%)

Sep/18Sep/19

50.4

48.3

－2.1

－4.1

－3.8

47.6

45.5

－2.1

－4.4

－3.6

34.0

31.3

－2.7

－7.9

－2.5

33.4

30.9

－2.5

－7.4

－2.5

0.6

0.4

－0.2

－35.5

0

13.6

14.2

＋0.6

＋4.5

－1.1

2.8

2.8

0

＋0.5

－0.1

Cost of Sales

23.8

23.8

0

0

－

SG&A

23.7

23.8

＋0.1

＋0.1

－

Operating Income

2.9

0.8

－2.1

－72.5

－1.5

Ordinary Income

3.2

1.1

－2.1

－66.2

－1.4

Net Income

2.2

0.8

－1.4

－62.4

－1.1

（unit : ¥billion）

Net Sales

Ethical drugs
business

Sales of new
ethical drugs

Japan
Overseas

Generic drugs

Healthcare BusinessChangeAnnounced on
May 13, 2019

■Net Sales and Operating Income: Difference from Original Forecast
Net Sales: In new ethical drugs (Japan), results remained largely favorable for mainstay products. However, net sales fell short ofprojections mainly because the supply of DESALEX was determined to resume in November and the production / marketing
approval of Lasvic Tablets, which had been ready for release, was postponed to September.

Operating Income: Profit was lower than the initial forecast, reflecting a decline in gross profit mainly attributable to lower-than-projected net sales,
despite efforts for the reduction of selling, general and administrative expenses.

7

Main Product Sales Update（unit : ¥billion）

Sep/18Sep/19ChangeChange(%)

Change(forecast)
Announced on
May 13, 2019

Flutiform(Combination drug for asthma treatment)

Desalex(Antiallergic Agent)

Kipresfor adult(Leukotriene Receptor Antagonist)for children
Nasonex（Spray type allergic rhinitis remedy）

Uritos（Kyorin）(Therapeutic agent for overactive bladder)

Beova(β3 adrenergic receptor agonist overactive bladdertherapeutics )Pentasa(Ulcerative colitis andCrohn’s disease treatment)

Mucodyne（Mucoregulant）

6.1
2.8
2.9
3.3
1.3
3.5

6.7
0
2.4
3.0
2.7
3.0

＋0.6

＋10.3

＋0.1

－2.8

－

－1.8

－0.5

－15.4

＋0.2

－0.3

－9.6

＋0.3

＋1.4

＋110.3

－0.4

－0.5

－12.9

－0.1

ー

0.6

＋0.6

－

－0.1

7.1
3.1

6.8
2.8

－0.3

－5.4

＋0.5

－0.3

－9.7

＋0.1

5.3
ー

5.4
0.4

＋0.1

＋2.5

0

＋0.4

－

－

1.1

1.1

0

－1.1

－0.1

..

MONTELUKAST Tablets “KM”
（LT receptor antagonist）

Mometasone Nasal 50mg “KYORIN”（Spray type allergic rhinitis remedy）

Milton(Disinfectant)

We released a revision to our second-quarter financial results forecast on November 5, 2019 but these comparisonswith the forecast show differences from the forecast announced on May 13, 2019.

8

Trends of mainstay products and Generic drugs

9■Respiratory/Otolaryngology（ Units: ¥ billion ）Flutiform 【Anti-asthmatic】
14.1

14.0

13.1
11.9

12.0

■ Status in first half 2019

10.1

10.0
8.0

14.0

7.4

7.4

7.0

2nd
half

¥56.7bln（FY18 first half） ⇒ ¥60.8bln（FY19 first half） ※1

share of Flutiform sales

6.5

7.2

ICS/LABA market ： expand 7.2%

11.9%（FY18 first half ） ⇒ 12.6％（FY19 first half ） ※2

5.5

6.0

■ effort for FY2019

4.2

4.0
2.0

4.5

5.4

6.1

6.7

6.6

3.0

0.0
16/3

17/3

18/3

19/3

20/3

20/3

revisedforecast

1sthalfSecure the positioning of a first-line drug for thetreatment of asthma
・Attract attention to the clinical impact from a patient withsymptoms
・The agent spreads into the overall lung, including
central and peripheral areas.
・Easy to use for inhalation

forecast※1sthalf ： actual※1,2 Copyright © 2019 IQVIA. Calculated based on MIDAS DEC 2018.4-9 , 2019.4-9Reprinted with permission

10■Respiratory/Otolaryngology（ Units: ¥ billion ）Desalex(Antiallergic Agent)

Desalex8.0

8■MSD has completed the pharmaceutical procedures

6

4.9

6.1

3.7

4
4.0

2
0

Resumption of supply

0.9

0.9

17/3

18/3

20/3

20/3

revisedforecast

1st
half

Nasonex Spray type allergic rhinitis remedy）（（ Units: ¥ billion ）

12.8

11.5

8.0
1.5

3.5

4
2
0

◆We will strive to spread the product among users by spotlighting its clinical effects,
interactions and safety again. Through such efforts, we will increase the number ofcases in which the product is adopted while also reviving treatments .

Status in first half 2019106

¥68.8bin（FY18 first half） ⇒ ¥71.1bin （FY19 first half） ※1

Nasonex

128◆Antihistamine market： expand 3.4%

■ effort for FY2019

forecast

14

of inventories considered necessary for stable supply thereafter.

Status in first half 2019

1.8

19/3

◆Efforts will be made to ensure the resumption of supply and the securing■the date of resumption of supply: November 18,2019(estimate)

5.0

2.8
1.0

2nd
half

・Acquired certification as an overseas manufacturer of drug substance storage
facilities.
・Acquired approval for changes to the production/marketing approval document.

1.3
19/3

0.4
2.7
20/3
revisedforecast◆Spray type allergic rhinitis remedy market : expand 1.3%

8.1
(AG)

1.9

¥15.5bin（FY18 first half） ⇒ ¥15.7bin （FY19 first half） ※1

AG

2nd

6.2

1st
half
※1sthalf ：actual

36.4％ （FY18 first half） ⇒ 31.7％ （FY19 first half） ※2●Released Mometasone Nasal（AG）:August 2019

half
(AG)

◆share of Nasonex sales

Nasonex■ effort for FY2019◆With a focus on ear and nose treatments, we will propose the proper use of DESALEX

20/3
forecast

and KIPRES (Montelukast KM) based on symptoms. In doing so, we will continue toprovide optimal rhinitis treatments in response to needs※1,2 Copyright © 2019 IQVIA. Calculated based on MIDAS DEC 2018.4-9 , 2019.4-9Reprinted with permission

11

■Urology（ Units: ¥ billion ）

7.5

8
6

3.8

OAB market（ Units: ¥ billion ）10

Uritos and Beova

Uritos（Overactive bladder)
7.5

3.7

7.2

3.6

8.7

8

6.6
3.1

4

2.2

0.7

5.9

6.0

29

2.9

3.7

3.8

3.6

3.5

3.0

6

2nd
half

4

7.5

7.5

7.2

6.6

0.6

3.0

1st

3.1 half

18/3

19/3

20/3

20/3

revisedforecast

3.1

Beova
Uritos

17/3

18/3

19/3

20/3

20/3

revisedforecast

Status in first half 2019
◆ OAB market expand：5.2%

Beova（Overactive bladder)44.3bln（FY18 first half） ⇒ 46.6bln（FY19 first half）※1

2.8

3

0.7

forecast

forecast ※1sthalf : actual（ Units: ¥ billion ）

1st
half

0
16/3

17/3

2.9

2.9

0
16/3

1.7
2nd
half

2
2

8.5

◆share of Uritos sales

8.6% （FY18 first half） ⇒ 7.5% （FY19 first half）※2

2.5◆ share of Beova sales

1.8% （FY19 first half）※2

2

2.2

1.8

2nd
half

1

effort for FY2019◆Uritos：Succeeded in acceptable product positioning(OAB patients with nocturia)◆Beova：The limits on prescription periods were removed (December 2019)

0.7

0.6

0.7

19/3

20/3

20/3

revisedforecast

0
16/3

17/3

18/3

forecast ※1sthalf : actual

1st
half

【 Popularize the drug to make sure it is chosen as a first-line medicine for OAB treatment】

・The treatment may be applied to different types of OAB patients.
・Clinical effects, interactions and safety are featured.
・ Increase the number of medical organizations that use the drug for prescriptions and thenumber of treatments with the drug, with an eye on removing the limit on prescription periods.
※1,2 Copyright © 2019 IQVIA. Calculated based on MIDAS DEC 2018.4-9 , 2019.4-9. Reprinted with permission

12

■Status of Generic Drugs■Generic drugs Sales

35（unit : ¥billion）

30

27.7

14.7

20

10

5
0

32.2

31.0

25.0

25

15

29.3

Kei

15.5

15.7

16.8

16.8

14.7

8.1

7.4
16/3

2nd
half

10.3
17/3

13.0

13.6

18/3

19/3

15.3

14.2

20/3

20/3

revisedforecast

1st
half

forecast（unit : ¥billion）■MONTELUKAST AG and Mometasone AG
13.3
11.9
11.7
1.4

15

10

8.2

5

6.7

6.6

6.1
0.4

6.4
5.0

5.3

18/3

19/3

13.5
1.9

2nd
half

11.6 MONTE

16/3

17/3

◆ Promotion of AG strategy
MONTELUKAST AG ￥5.4bin(＋￥0.1bln)
Mometasone AG ￥0.4bin(＋￥0.4bln)
Acquired production/marketing approval for
IMIDAFENACIN (Uritos) AG.

◆ Generic drugs released in June 2019
Silodosin tablets 2mg / 4mg, OD 2mg / 4mg
Mecobalamin tablets 500μg■ Effort for FY2019

LUKAST

1sthalf

Actions for an authorized generic drug (AG)

5.4

・Aim to achieve a large market share of more than 50%
for MONTELUKAST AG in the GE market

1.8

0

Mome
tasone■ Status in first half 2019

20/3

20/3

revisedforecast

forecast

13

Consolidated Financial Resultsand Forecast

14Consolidated Financial Results Forecast
for the Year Ending March 31, 2020
※The results forecasts for the fiscal year ending March 31, 2020 announced on May 13, 2019 are revised.

FY2018Y/Y

FY2019（unit : ¥billion）
Versus the

FY2019revised（revised forecast)

ChangeChange(%)(original forecast)

113.6

109.4

－4.2

－3.7

114.1

－4.7

107.9

103.4

－4.5

－4.1

108.0

－4.6

78.5

72.4

－6.1

－7.8

75.8

－3.4

Japan

77.7

71.0

－6.7

－8.6

74.4

－3.4

Overseas

0.8

1.4

＋0.6

＋68.7

1.3

＋0.1

29.3

31.0

＋1.7

＋5.7

32.2

－1.2

Healthcare Business

5.8

5.9

＋0.1

＋2.4

6.1

－0.2

Operating Income

9.0

6.5

－2.5

－27.6

9.1

－2.6

Ordinary Income

9.4

7.1

－2.3

－24.8

9.6

－2.5

Net Income

6.9

5.4

－1.5

－21.4

7.1

－1.7

Net sales

Ethical drugs
businessSalesof new
ethicaldrugs

Generic drugs

forecast■Main factors behind revision of forecast： we revised forecast of the sales because reviewed the sales of DESALEX Tablets 5 mg that was determined to resume supply in November and Lasvic Tablets 75 mg that wasgiven the marketing approval in September with a result of taking financial results in the first half.
Operating income : Gross profit decreased due to a fall in net sales and rise in the cost of sale ratio (approximately 0.5 point). With respect to selling expenses and research and development expenses,
certain reductions were made to initial projections.
Net sales■ Main factors in year-on-year change： In new ethical drugs (Japan), sales of new drugs such as Beova, DESALEX and Lasvic Tablets will increase. However, net sales are expected to decline mainly due to a decline in
the number of prescriptions with Nosonex and long-listed drugs . In generic drugs, sales are expected to rise, chiefly reflecting the release of MOMETASONE AG.
Operating income ： Gross profit will decrease due to a fall in net sales, although the cost of sales ratio is expected to decline. （ the cost of sales ratio : down about 0.5points）
increase SG & A expenses（ SG&A ratio (excluding R&D expenses) ：up about 2points. Decrease R&D expenses ¥0.2bln : ¥10.8bln→¥10.6bln
Net sales

15Forecast of Mainstay Product Sales※The results forecasts for the fiscal year ending March 31, 2020 announced on May 13, 2019 are revised.
Y/Y

FY2019FY2018
Flutiform(Combination drug for asthma treatment)

Desalex(Antiallergic Agent)（Spray type allergic rhinitis remedy）

Uritos（Kyorin）(Therapeutic agent for overactive bladder)

Beova(β3 adrenergic receptor agonist overactive bladdertherapeutics )Pentasa(Ulcerative colitis andCrohn’s disease treatment)

Mucodyne（Mucoregulant）

－0.1

－
＋1.4

2.3

－0.1

－1.5

－24.5

－1.3

－17.4

－6.6

－51.4

6.6

－0.7

－10.7

0.7

2.8

＋2.1

＋278.6

13.5

12.7
6.1

－0.8

－6.3

－0.7

－9.6

－0.4

－3.3

０

11.5
1.8

＋1.8

2.2

2.2

0

12.8

6.8

Change

11.6
1.9

＋34.4

7.6

revised forecast

＋0.1

＋1.3

3.7

(original
forecast)

Versus the

14.0
8.0
4.5
6.1
6.2
6.0
2.5
12.0
6.0

＋8.0

for children
Nasonex

Change(%)

＋1.0

6.2

for adult

Change

14.1
5.0
4.7
6.3
6.2
5.9

13.1

(Leukotriene Receptor Antagonist)

Kipres（revised
forecast）

FY2019（ Units: ¥ billion ）

－3.0
＋0.2
＋0.2

0
－0.1
＋0.3
＋0.7
＋0.1

.

MONTELUKAST Tablets “KM”
（LT receptor antagonist）

Mometasone Nasal 50mg “KYORIN”（Spray type allergic rhinitis remedy）

11.9

－0.1

.

Milton(Disinfectant)16

Shareholder Returns
Basic Policy
・While maintaining the sound financial base, we aim to improve the capital efficiency
through growth investment and returns to shareholders.
・We will maintain stable dividends taking DOE (Dividend on Equity ratio) into account.
Dividend per share for fiscal 2019 (estimate): ¥75 (including interim dividend of ¥30)

Dividends

Dividend pershare (Yen)FY2017FY2018FY2019（forecast）

¥58

¥75

¥75

（interim ¥30）

（interim ¥30）

（interim ¥20）

17

Status of development pipeline18

Drug Development Pipeline:
schedule in FY2019
shedule in FY19 [May 13, 2019]
development code

Ad-SGE-REIC

PhⅠ

PhⅡ

PhⅢ

application

Approval/

2017/6

Preparation

Expecting tocreate an
Application
in FY19

LaunchEnd of the PhⅠ／PhⅡPhⅡStart 2018/6

Respiratory

KRP-108P
KRP-AM1977X

FY19
Expected
Release2017/4

Infections

KRP-AM1977Y

Preparation

KRP-116D

2017/3

Preparation

Urological

KRP-N118

Expecting tocreate an
Application
in FY19
Expecting tocreate an
Application
in FY19

PhⅡStart2018/8(SK-1404)※ MK-7264, a drug for chronic coughing: MSD is working on Phase III development. Concluded a memorandum of
understanding for sales collaboration（2019/5）.

【 Licensing development】
開発コード

FPR2 agonist
program

KRP-203

導出先

開発段階

特徴

BMS

PhⅠ

FPR-2 agonists that mainly inhibit the
migration of neutrophils and exhibit anti-inflammatory action.
Therapy area：Non-disclosure

Implementing
licensing activities

PhⅠ

Sphingosine-1-Phosphate Receptor Agonist
Therapy area：GvHD

Because Novartis (licensee) decided to discontinue development of KRP-203 for strategic reasons, Kyorin receive the returnof development rights.

19

Drug Development Pipeline:
Progress in FY2019 2Q and schedule in FY2019
shedule in FY19

progress in FY19 2Q [ November 7,2019]

PhⅢ

application

Approval/

2017/6

2019/7

Application

KRP-AM1977X

2017/4

2019/9KRP-AM1977Y

2019/10

Application

Preparation

Expecting tocreate an
Application
in FY19development code

Ad-SGE-REIC

PhⅠ

PhⅡ

LaunchEnd of the PhⅠ／PhⅡPhⅡStart 2018/6

Respiratory

KRP-108P

FY19
Expected
ReleaseInfections

KRP-116D

2017/3

Urological

KRP-N118

PhⅡStart2018/8(SK-1404)※ MK-7264, a drug for chronic coughing: MSD is working on Phase III development. Concluded a memorandum of
understanding for sales collaboration（2019/5）.

【 Licensing development】
開発コード

FPR2 agonist
program

KRP-203

導出先

開発段階

特徴

BMS

PhⅠ

FPR-2 agonists that mainly inhibit the
migration of neutrophils and exhibit anti-inflammatory action.
Therapy area：Non-disclosure

Implementing
licensing activities

PhⅠ

Sphingosine-1-Phosphate Receptor Agonist
Therapy area：GvHD

Because Novartis (licensee) decided to discontinue development of KRP-203 for strategic reasons, Kyorin receive
the return of development rights.

20Initiatives toward realization of
the long-term vision “HOPE 100”

21

For continuous growth（Refinement of pharmaceutical Business）
Medium-term management plan “HOPE100－Stage 2－” （2016-2019）＜Drug Discovery＞＜New Drug Business＞■Initiatives for first-in-class
New drug discovery■ Increase in the Ratio of
New Drugs Group・Establishment of system forcontinual generation of
innovative new drugs

・Make the four new drugs (including
those developed in-house)
the driving force＜ Generic Drugs Business ＞■Promotion of Generic Drugs
Business by Making the Mostof Its Characteristics
・promotion of AG strategy＜ New businesses ＞■ Development of thediagnostic business andestablishment of a foundation

Progress in FY2019◆ Lasvic tablets◆FPR2 Agonist Program： Presented three themes at two overseas
academic conferences.

◆KRP-116D：Presented two themes at two academic
conferences.

： Production/marketing approval acquired
Expected Release in FY2019◆KRP-AM1977Y： Applied for production / marketing approval（October）◆ Mometasone Nasal
Released AG(August)◆Beova： It will be removed the limit on prescription
periods （December 1）◆Desalex： Resumption of supply is estimated on
November 18◆ Flutiform◆ Acquired production /marketing approval for
IMIDAFENACIN (Uritos)AG◆Microchannel-based Genetic
Measurement Device｢GeneSoC®｣,
special-purpose measurementchip
To be released on November 11.

（August）： Applied for production / marketing approvalfor KRP-108P（August）

22

<Drug Discovery>

FPR2 Agonist Program
BMS and Kyorin have given a total of three presentations on this FPR2 agonist(development code: BMS-986235/LAR-1219) at 2 academic conferences

American Chemical Society National Meeting (San Diego)■Aug. 28, 2019:Poster presentation
Discovery of clinical candidate, BMS-986235/LAR-1219, design and optimization of selective 4phenylpyrrolidinone FPR2 agonist■ Aug. 28, 2019:Oral presentation
Discovery of clinical candidate, BMS-986235/LAR-1219: Selective FPR2 agonist for prevention of heart
failureEuropean Society of Cardiology Congress (Paris, France)■Sept. 1, 2019:Oral presentation
A selective small-molecule formyl peptide receptor 2 agonist promotes a pro-resolution macrophage
phenotype and improves left ventricular structure-function relationships post myocardial infarction

23

<Drug Discovery>

Summary of oral presentation at ACS• Discovery of a conformationally constrained urea followed by
optimization of FPR2 potency and selectivity, let to theidentification of a highly potent and selective FPR2 agonist
with excellent PK and ADME properties.
• Significant improvements of remodeling and functional
endpoints observed in a mouse heart failure model• First example of efficacy in a heart failure model with daily
oral dosing of a selective, small molecule FPR2 agonist• BMS-986235/LAR-1219 is currently in Phase 1 clinical trials.

24

<Drug Discovery>

Therapeutic agent for interstitial cystitis "KRP-116D"(Name of Ingredient: Dimethyl Sulfoxide)

Status of Development
Phase 3 study (completed) ◆ Application in preparation＊Under development for handling unapproved drugs and off-label drugs

Study type: multicenter, randomized, double-blinded, placebo-controlled, parallel group, comparative study
Disease name: interstitial cystitis
Primary endpoint: O’Leary & Sant interstitial cystitis symptom index (ICSI)
Secondary endpoints: O’Leary & Sant interstitial cystitis problem index (ICPI), voiding symptoms, and safety, etc.
Number of cases: 96
Dosage and Administration, usage: one intravesical instillation of 50 mL once every two weeks
Remarks: designated orphan drug

Study results
This phase 3 study confirmed the superiority and safety of this compound compared to placebo(Its superiority compared to placebo could be proven for the first time worldwide)
Presentations at academic conferences related to this phase 3 study
Name of academic conference: The 26th Japanese Continence Society (Sept. 12 to 14, 2019)[Topic] Therapeutic effects of KRP-116D (50% dimetyl sulfoxide) in Japanese patients with interstitial cystitis

Name of academic conference: ICS2019 (Sept. 3 to 6, 2019)[Topic] A randomized, double-blinded, placebo-controlled multicenter trial on the efficacy and safety of theintravesical instillation of KRP-116D (50％ dimetyl sulfoxide) in Japanese patients with interstitial
cystitis/bladder pain syndrome25

<Drug Discovery>

Efficacy endpoints (ICSI, bladder diary )Changes from baseline

Bladder diary (after 12 weeks)(secondary endpoints)

Changes in ICSI over time(primary endpoint)
Week 00

Week 4

Week 800⊿Mean frequency ofurination per day

Placebo
KRP-116D-1-2-2.0665-1

Placebo
KRP-116D

-2

-3

-1.75

-4
-3.86

-5

**

-6

-2.496-7-3

Mean single voided volume-3.4072

-4

**
-5

*
-6

60
⊿Mean single voided
volume (mL)⊿ICSI score

Mean frequency of urination per day

Week 12

Placebo
KRP-116D

50

38.8 **

40

30
20

14

10
LSmean ± SE

* ；P<0.05** ；P<0.01

026

<Drug Discovery>

Overview of study results■Regarding the primary endpoint (ICSI) the superiority of
KRP-116D compared to placebo could be verified, and thus
the goal of this study was achieved■The efficacy of KRP-116D was confirmed for all endpoints,
including subjective and objective endpoints■The incidence of adverse events for which a causal
relationship could not be denied was 59.2％ in the KRP-116D
group, and 27.7％ in the placebo group, and no serious
adverse reactions were observed

27

＜New Drug Business＞"KRP-AM1977X" and "KRP-AM1977Y"
 Generic name: lascufloxacin hydrochloride Abbreviation: LSFX
 Classification: quinolone antimicrobial[Aim of the development of this drug]
Our aim was to develop a new therapeutic agent that is effective for treatment of pneumonia, etc.,
and with low risks regarding safety and tolerance
・To strengthen antibacterial activity against bacteria that cause respiratory tract and ENT infections(particularly aerobic Gram-positive bacteria and anaerobic bacteria)
・Improve its transfer to tissues of the lung, ear, nose and throat
・Exerts sufficient antibacterial activity at the therapeutic target, and impedes the expression of resistantbacteria, while suppressing systemic exposure

Lasvic tablets 75mg: Received
marketing approval in Sept. 2019
Indications: Pharyngeal laryngitis, tonsillitis (including
peritonsillitis and peritonsillar abscess), acutebronchitis, pneumonia, secondary infection of chronic
respiratory lesions, otitis media, and sinusitis
Dosage and Administration: 75mg orally once daily

KRP-AM1977Y: Application was
submitted in Oct. 2019
Diseases included in the phase 3 study: Communityacquired pneumonia, secondary infection of chronic
respiratory lesions, aspiration pneumonia, pulmonary
suppuration, and lung abscessDosage and Administration in the phase 3 study:
Intravenous administration of 150mg once daily(administration of double dose on the starting day ofadministration)
28

<Diagnostic business>

Microchannel-based Genetic Measurement Device ｢GeneSoC®｣
GeneSoC：Gene
Sensor on aSensor
Chip on a Chip
CharacteristicsGeneSoC：Gene・Rapid detection of genes based on the technology of ultrafast quantitative
PCR* （5-15 minutes）
・ High-sensitivity detection is possible with a trace amount of the sample
immediately after infection
・ A compact, desktop PCR device eyeing POCT*
Identification of pathogenic bacteria of infection by POCT and
improvement of treatment with the choice of an appropriate
antibacterial agent
Up to 4 Detection Units can be added and thesimultaneous test of multiple samples is possible

Control Unit 36×30×15(cm), 3.6 kg■ To be released on November 11(as laboratory equipment)
・Microchannel-based Genetic
Measurement Device ｢GeneSoC®｣,
special-purpose measurement chip・Dedicated analytical reagents will be
released gradually.
■ Aim to launch dedicated in-vitro diagnostics
kits in 2021 after filing application as a
medical device.

※1 PCR (Polymerase Chain Reaction): A technique of selectively amplifying DNA arrangements.
※2 POCT (Point of Care Testing): Testing carried out by a healthcare worker at a patient’s bedside.

sample(around20μL)

Reaction mixture
movingrepeatedly moves between two
temperature zones using microblowers

Measurement chip 7.6×2.6(cm)

In GeneSoC®, a small volume of reaction
mixture repeatedly moves between two
temperature zones in a short microchannel forthermal cycling using microblowers. With ourtechnology, nucleic acid amplification occurs
faster, with a more compact instrument, andless power consumption.

29

Our group's efforts in the field of infectious diseases
Diagnostic equipment
and diagnostics

Microchannel-based Genetic

Diagnosis

Measurement Device ｢GeneSoC®｣※ To be released on November 11 (as laboratory equipment)

Ethical drugs

Treatment※ Production/marketing approval acquired /Not listed in the drug pricing standard

Prevention®
Oral Quinolone Antibacterial Agent ｢Lasvic tablets 75㎎｣

Multi-purpose
disinfectant cleaner

broad-spectrum antibiotic

Disinfectant｢KRP-AM1977Y｣｢Baccidal tablets｣｢RUBYSTA®｣｢Milton｣Aim to establish a business model of infectious diseases
about Prevention, Diagnosis and Treatment.