Interim Term Financial Results Ended
September 2020

November 6 , 2020
KYORIN Holdings, Inc.
President Yutaka Ogihara➢ Outline of Consolidated Financial Results• Trends of mainstay products➢ Consolidated Financial Forecast➢ Status of R&D Pipeline➢ Initiative toward realization of
the long-term vision ”HOPE100”
1

Impact of COVID-19 on our Business■Promotion Activities etc.
●The spread of COVID-19 sets back sales progress・Patient’s suppressive behavior to medical consultation diminishes KYORIN
pharmaceutical’s main products market(exp. Respiratory, ENT, Pediatrics)
・Decrease of infected patients stagnated antimicrobial agent market
・Voluntary restriction on MR activities results in delay in market penetration of
the new drug groups■R&D●Work from home under the national sate of emergency affected
some project, overall development schedule does not fall far behind■Production＆Procurement●No influence by COVID-19
・Health check(ex. body temperature) and infection control keep production
operation normal in every facilities
・For stable supply, procurement management(ex. Impact forecast) of
materials enhanced2

Outline of Consolidated Financial Results3Outline of Consolidated Financial Results for
the Interim Term Ended September 2020
Change(forecast)

Sep/19Sep/20Net Sales

48.3

47.7

－0.6

－1.2

－5.1

Operating
Income

0.8

1.5

＋0.7

+91.7

－0.9

Ordinary
Income

1.1

1.8

＋0.7

＋68.5

－0.8

Net Income

0.8

2.1

＋1.3

＋154.0＋0.2（Units：¥billion）

ChangeChange(%)

Announced on
May 12,2020※We released a revision to our second-quarter financial results forecast on November 2, 2020 but thesecomparisons with the forecast show differences from the forecast announced on May 12, 2020.
4

Segment Sales and Breakdown of Gain and Loss

（Units: ¥billion）

Sep/19Sep/20ChangeChangeChange(forecast)(%)

Announced on
May 12,2020

48.3

47.7

－0.6

－1.2

－5.1

New ethical drugs, etc.
（Japan）

33.7

32.9

－0.8

－2.6

－3.9

New ethical drugs（Overseas）

0.4

0.5

+0.1

+35.1

+0.2

Generic drugs

14.2

14.4

＋0.2

＋1.3

－1.2

Cost of Sales

23.8

22.9

－0.9

－3.5

－

SG&A
（R&D）

23.8

23.3

(5.2)

(5.2)

－0.5
(0)

－1.9
(+0.2)－（＋0.4)

Operating Income

0.8

1.5

+0.7

+91.7

－0.9

Ordinary Income

1.1

1.8

＋0.7

＋68.5

－0.8

Net Income

0.8

2.1

＋1.3

＋154.0

＋0.2

Sales

※We released a revision to our second-quarter financial results forecast on November 2, 2020 but these comparisons withthe forecast show differences from the forecast announced on May 12, 2020
The classification of reporting segment ("Prescription drugs business" and "Healthcare business") was consolidated to a single segment from the first quarter consolidated financial
results for the fiscal year ending March 31, 2021.Along with this, the classification of sales was changed to combine the existing “New ethical drugs (Japan)” and “healthcare
business” to "New ethical drugs, etc. (Japan)". There is no change in "New ethical drugs (overseas)" and "Generic drugs".

5

Highlights of Business Performance:①Net sales（Units: ¥billion）

50

48.3

40

14.2
0.4

47.7

【Net Sales ¥－0.6bln】

14.4

New ethical drugs, etc.(Japan)¥－0.8bln

0.530

・New drugs "Beova" and "Desalex“ etc. grew・Market slump and decrease in sales of long-listed
products (Nasonex, Kipres, Mucodyne etc.)
・Environmental hygiene products grew

New ethical drugs（Overseas）
20

33.7

32.9

・ Transfer of intellectual property and APIs
(KRP-203)

Generic drugs
10¥+0.1bln¥＋0.2bln

・Although sales declined due to drug price revisions,sales increase in Nasonex AG, launch of Uritos AG
and new generic drugs in June contributed tosales

0
Sep/2019

Sep/2020
6

Highlights of Business Performance :②Operating Income（Units：¥billion）

1.5【Operating Income +¥0.7 bln】

1.5+¥0.3 bln

－0.5

Net Sales decreased：¥0.6 bln year on
year

±0
1

Gross Profit increased

0.8

Cost of sales ratio decreased 1.2%
・Product mix
・Effort to reduce costs(Raw material
cost,etc)+0.3

R&D expenses Flat±¥0 bln■¥5.2bln（Sep/2019）⇒¥5.2bln（Sep/20）

0.5

SG&A(exclude R&D) expenses
decrease－¥0.5bln■ ¥18.6bln（Sep/19）⇒¥18.1bln（Sep/20）

0・Decrease of selling and general expenses

R&D
Operating Gross Profit
expenses
IncomeSep/2019

SG&A(exclude R&D）

Operating
IncomeSep/2020
7

Highlights of Business Performance:③Change (forecast)（Units：¥billion）

Sep/19Sep/20ChangeChange(%)

Change(forecast)
Announced on
May 12,2020

48.3

47.7

－0.6

－1.2

－5.1

New ethical drugs, etc.(Japan)

33.7

32.9

－0.8

－2.6

－3.9

New ethical drugs (Overseas)

0.4

0.5

+0.1

+35.1

+0.2

Generic drugs

14.2

14.4

＋0.2

＋1.3

－1.2

Cost of Sales

23.8

22.9

－0.9

－3.5

－

SG&A
（R&D）

23.8

23.3

(5.2)

(5.2)

－0.5
(0)

－1.9
(+0.2)－(＋0.4)

Operating Income

0.8

1.5

+0.7

+91.7

－0.9

Ordinary Income

1.1

1.8

＋0.7

＋68.5

－0.8

Net Income

0.8

2.1

＋1.3

＋154.0＋0.2

Net Sales■Difference from Original Forecast(May 12, 2020)
Net Sales：Market slump of main products and MR activity restraint led the delay in market penetration of new drug groups (Lasvic
tablets, Desalex), and new ethical drugs, etc.(Japan) sales did not reach the forecast. Also General drugs sales were below theoriginal forecast.
Operating Income：Due to cost reduction and restriction on activities, selling expenses (excluding R&D) decreased. But decrease ofgross profit attributable to lower net sales could not be absorbed. As a result, original forecast fell short. R&D expenses increased
due to a lump-sum contract payment associated with license agreements were not included in the initial forecast.
Net Sales：Due to the partial exemption of repayment obligation for long-term debt from JST(Japan Science and Technology
Agency), debt exemption gain(¥1.1 bln) recorded and exceeded the initial forecast.

8

Main Product Sales Update
Change（単位：億円）Sep/19Flutiform(Combination drug for asthma treatment)

Desalex(Antiallergic Agent)

Beova(β3 adrenergic receptor agonist overactive
bladder therapeutics )Lasvic tablets(New quinolone synthetic antibacterial agent)

Pentasa(Ulcerative colitis andCrohn’s disease treatment)

New ethicaldrugs,etc.
(Japan)Uritos（Kyorin）(Overactive bladder)

Nasonex（Spray type allergic rhinitis remedy）

Kipresfor adult(Leukotriene Receptor Antagonist)for children
Mucodyne（Mucoregulant）

Milton(Disinfectant)

Rubysta(Disinfectant)

Sep/20ChangeChange(%)(forecast)
Announced on May
12,2020

6.7

6.4

－0.3

－5.6

－0.6

0

1.8

＋1.8

－

－1.3

0.6

3.8

＋3.2

＋496.9

＋0.3

－

0.2

＋0.2

－

－1.2

6.8

6.4

－0.4

－6.0

＋0.5

3.0

－1.4

－47.3

－0.2

2.7

1.6
0.6

－2.1

－76.4

0

2.4

1.7

－0.7

－30.5

－0.1

3.0

－1.2

－38.9

－0.4

2.8

1.8
1.4

－1.4

－48.0

－0.8

1.1

1.1

0

＋0.9

0

0.6

1.0

＋0.4

＋64.5

＋0.4

5.4

4.5

－0.9

－16.8

－0.2

0.4

0.9

＋0.5

＋142.8

0

－

0.3

+0.3

－

－0.1

..

Montelukast tablets “KM”
(Leukotriene Receptor Antagonist)

Generic
drugs

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

Imidafenacin tablets & OD
“KYORIN”Overactive bladder)※We released a revision to our second-quarter financial results forecast on November 2, 2020 but these comparisons with theforecast show differences from the forecast announced on May 12, 2020.

9

Trends of mainstay products
and Generic drugs

10Change of ethical drug market and numberof patients(First half of the fiscal year ending Mar.2021)
Ethical Drug Market in 2020

（Units：¥ bln）

（Unit：％）

102.4

101.8
95.7

1000

95.5

93.5

87.3

100

Status in first half 2020
■Ethical drug market

800
600

80

・Market side gradually recovered

60■Patients

1,021.8
400

869.4

834.6

723.4

852.6

812.7

200

40
20

0

・The number of patients decreased sincethe "state of emergency" issued in April.
(Especially ENT, Pediatrics)
・After the release of the emergency at theend of May, it showed a recovery trend

0
Apr

May

Jun

Jul

Aug

Sep

Copyright © 2020 IQVIA. Calculated based on MIDAS 2019.4-9,2020.4-9 Reprinted with permission（Unit：％）

Number of patients YonY(2020)

100
80

93

90％

81

76

76％

67

Forecast in second half 2020

57

60

47

■Trend of market and patients・ Market and patient numbers are recovering
to pre –COVID-19 spread
・ Revised sales plan on the premise thatcertain impacts remain,

40
20
May

Sep

May

Sep

May

Sep

May

Sep

0
Respiratory

ENT

Pediatrics

Source：Japan Medical Information Research Institute, Inc.

Total
JMIRI prescription database11

■Main Product Flutiform（Anti-asthmatic）（Units：bln）

12（Unit：％）ICS/LABA market

YonY

10

83.2

100

84.9
75.6

75.3

80

60

11.3
bln

4

7.6

8.2

8.4

7.8

7.8

40

20

0

0

May

Jun

Jul

Aug

14.5

15.0

7.9

8.2

7.9

2nd
half

5.4

6.1

6.7

6.4

7.0

1st
half

18/3

19/3

20/3

21/3

21/3

13.1
11.9

10
8

10.1

6.5

Sep

7.0

5.5

6

4

2

Apr

14.6

14
12

8
6

Flutiform

16

100.2％
83.8

sales（Units：bln）

2

4.5

0
17/3

revised original

Copyright © 2020 IQVIA. Calculated based on MIDAS 2019.4-9,2020.4-9 Reprinted with permission■ICS/LABA market： Shrink 15.9％

forecast forecast◼Status in first half 2020

¥60.8bln(FY19 first half) ⇒ ¥51.1bln(FY20 first half) ※1●Expand indications for pediatric asthma（June）●Patient’s suppressive behavior to medical consultationby the spread of COVID-19◼Effort for FY 2020
Establish the "First Choice for Asthma
Treatment" Position■Share of Flutiform sales：expand2.6％
12.6%（ FY19 first half ） ⇒ 15.2%(FY20 first half)※ 1
NHI price change 125aerosolized 120 for inhalation ▲4.96%（Compared with Apr.2019）※1 Copyright © 2020 IQVIA. Calculated based on MIDAS 2019.4-9,2020.4-9 Reprinted with permission●In addition to real interviews, lectures on asthma
management through Web●Expand target facilities (internal medicine / pediatrics)◆The second half year market to recover about 90% YoY
Aim for 100% or more of the initial forecast

12

■Main Product Beova/Uritos（OAB）（Units：bln）
113.6％

12
10
8

2

YonY

108.8

Sales
（Unit：％） （Units：bln）

99.8

7.3

6

3.5

80

7.2

7.9

8.1

7.5

7.4

60
40

4.0

4.5

4.7

4.4

4.4

20

Jun
market

Jul

Aug

3.7

2

0
18/3

0.7

0.6

19/3

20/3

Sep

β3 adrenergic receptor agonist

Copyright © 2020 IQVIA. Calculated based on MIDAS 2019.4-9,2020.4-9 Reprinted with permission◼Status in first half 2020

Sales
（Units：bln）

8

7.5

OAB market：expand 4.0％
¥46.6bln(FY 19 first half)⇒¥48.5bln（FY 20 first half）※1・β3 adrenergic receptor agonist market expanded●Share of Uritos sales

7.2

6

3.7

NIH price revision Beova▲0.86％、Uritos▲4.78％（ compared with Apr.2019)※Since Apr.2020, shipments to medical institutions has beenadjusted. Securing APIs and products that meet demands will taketime.
※1 Copyright © 2020 IQVIA. Calculated based on MIDAS 2019.4-9,2020.4-9 Reprinted with permission

3.5

1st
half

21/3

21/3

revisedoriginal

forecast

forecast

3.6

5.8

3.1
2.8

4

7.5%(FY19 first half)⇒4.1%(FY20 first half)※1●Imidafenacin tablets & OD “KYORIN” launched (Jun)

3.8

Uritos
6.6●Share of Beova sales
1.8%(FY19 first half)⇒8.9%(FY20 first half)※1

2nd
half

4.3

0

May

3.5

4

17/3

0
Apr

7.0

100

10.3
bln

5.6
bln

Beova

8

107.4
99.9

93.2

6
4

OAB market

2

2.2
3.8

3.6

3.5

3.0

0.6
1.6

2.7
0.9

2nd
half

1.8

1st
half

0
17/3

18/3

19/3

20/3

21/3

21/3

revisedoriginal

forecast

forecast13

■Main Product Desalex（Antiallergic Agent）（Units：bln）

Antihistamine market（Unit：％）

Sales（Units：bln）

Desalex

YonY

15

98.8
81.6％

8
84.4

78.4

88.4

84.9

7.5

100
80

10

6

4.9

15.2
bln
5

60

9.3

10.0

9.1

4

4.0

40

8.6

8.5

2
20

0

0

Apr

8.8

May

Jun

Jul

Aug

Sep

Copyright © 2020 IQVIA. Calculated based on MIDAS 2019.4-9,2020.4-9 Reprinted with permission

0

1.0

0.9

17/3

18/3

5.6

2nd
half

3.1

1st
half

5.6

3.7
0.9
2.8

2.6

19/3

20/3

0

Supply suspended:

1.8
21/3

21/3

reviseoriginal

forecast

forecast

about 10 months■Antihistamine market ：shrink 14.7%¥71.1bln(FY 19 first half))⇒ ¥60.7bln(FY 20 first half) ※1●Patient’s suppressive behavior to medical consultationby the spread of COVID-19■Share of Desalex sales
0%(FY 19 first half)⇒ 4.0% (FY 20 first half)※1●Dec. 18 single month：6.3%※2(Before supply suspension)●Sep.20 single month：4.6%※1（After resuming supply）
NHI price revision ▲4.73% （compared with Apr.2019）※1 Copyright © 2020 IQVIA. Calculated based on MIDAS 2019.4-9,2020.4-9 Reprinted with permission※2 Copyright © 2020 IQVIA. Calculated based on MIDAS 2018.12 Reprinted with permission◼Status in first half 2020
●Due to market shrinkage by patient’s suppressive
behavior, product dissemination was insufficient during thepollinosis season after resuming supply in November 2019.

◼Effort for FY2020
Promoting "high effect", "less drowsiness", and"easy to use"
● No. 1 prescription acquisition rate in otolaryngology● Focus on acquiring prescriptions in internal medicine◆ Due to market recovery, the second half year market is
to be about 90% of the previous year
Aim for a share of >10% through web lectures etc.

14

■Main Product Lasvic（Oral new quinolone synthetic antibacterial agent)（Units：bln）

Oral antimicrobial market

YonY◆ market（Unit：％）

quinolone

100

5.5
4.9

4.7
69.5%

48.1

4.1
4

80

3
61.3
47.2

2

4.9

4.0

4
62.9%

Lasvic5

6.7bln6

Sales（Units：bln）

65.7
53.1

68.5
55.4

65.5

60

52.4

40

38.2
20

2

1.7

1

1.6
1.1

0

0

Apr

May

Jun

Jul

Aug

Sep

0

¥48.7bln (FY 19 first half) ⇒ ¥30.7bln (FY 20 first half)※1●In addition to curbing medical consultations, preventing
infection (washing hands, gargling, wearing masks, etc.)
has reduced the number of infectious diseases, and themarket shrunk significantly■Share of Lasvic sales 1.4％ (FY 20 first half)※1
NHI price revision ▲2.2％ （compared with Jan.2020）※1 Copyright © 2020 IQVIA. Calculated based on MIDAS 2019.4-9,2020.4-9 Reprinted with permission

2nd
half

1.4

1st
half

0.2
20/3

Copyright © 2020 IQVIA. Calculated based on MIDAS 2019.4-9,2020.4-9 Reprinted with permission■Oral antimicrobial market：shrink36.9％

2.6

21/3

21/3

revisedoriginal

forecast

forecast◼Status in first half 2020

●The shrinking market and voluntary restraint of MR
activities led insufficient to disseminate the product.

◼Effort for FY2020
Promote proper use and product dissemination●Increase prescriptions and achieve a market share of >3% byimproving product understanding through web lectures.

◆The second half market :about 50% YoY◆Injection (KRP-AM1977Y) to be approved & launched
in FY202015

■Status of Generic Drugs
Sales（Units：bln）

Generic Drugs
33.0

35
30
25

27.7

29.3

31.0

25.0
14.7

20

15.7

34.9

18.6

16.8

19.3

2nd
half

Action for an authorized generic drug(AG)14.7●Montelukast AG（for Adult）Keep >50% share in GE market

15（¥4.5bln）

10
5

10.3

13.0

13.6

14.4

14.2

15.6

1st
half

17/3

18/3

Sales
（Units：bln）

19/3

20/3

21/3

21/3

revisedoriginal

forecast

forecast■AG（3products）

16

14.3

14.5

tablets, Dutasteride Capsules AV etc.

15.2

14
11.7

12

6
4

8.5
8.2

6.7

8.8

9.2

2nd
half

6.6

5.0

5.3

5.8

18/3

19/3

20/3

5.7

6.0

1.8
17/3

Promotion of AG strategy●Aim to achieve a market share of more than 50% foreach AG product in GE market

Expand sales of new launches

6.4

2
0

◼Effort for FY2020

11.9

10

●Mometasone AG expanded（¥0.9bln）●Imidafenacin AG launched（Jun）（¥0.3bln）

GE drugs released in Jun 2020
( 7ingredients 13items )Memantine hydrochloride OD, Levocetirizine hydrochloride

0

8◼Status in first half 2020

21/3

21/3

revisedoriginal

forecast

forecast

1st

half

●To be released in Dec 2020(2ingredients 4items)
Pregabalin OD Tablets 25/75/150mg,LoreAce Combination
Tablets

16

Consolidated Financial
Forecast

17

Consolidated Financial Forecast in FY2020
FY2019FY 2020

FY2020

YoY（Original
forecast）

Versus therevised forecast（revised
forecast）

ChangeChange(%)

110.0

108.0

－2.0

－1.8

115.5

－7.5

New ethical drugs,etc.(Japan)

77.5

73.8

－3.7

－4.8

79.7

－5.9

New ethical drugs(Overseas)

1.5

1.1

－0.4

－26.2

1.0

+0.1

Generic drugs

31.0

33.0

+2.0

+6.6

34.9

－1.9

Operating Income

7.5

7.8

+0.3

+4.0

9.7

－1.9

Ordinary Income

8.2

8.4

+0.2

+2.7

10.2

－1.8

Net Income

6.1

7.2

+1.1

+17.1

7.6

－0.4

（Units：¥billion）

Net sales

Change■Main factors behind revision of forecast
Net sales：
Operation income:Net income：New ethical drugs, etc.(Japan) and Generic drugs revised downward based on the result of the first half and sales reduction
by COVID-19.
Gross profit will be decreased due to a fall in sales. Selling and SG&A expenses(excluding R&D) will be reduced. R&D expenses
will be increased ¥0.4bln due to a lump-sum contract payment associated with license agreements for the development ofcandidate products (¥9.6bln⇒¥10.0bln).
Due to the partial exemption of repayment obligation for long-term debt from JST(Japan Science and Technology Agency), debt
exemption gain(¥1.1 bln) was recorded as extraordinary profit.

■Main factors in YoY change
Net sales：
Operating income：

While in New ethical drugs, etc.(Japan), "Beova“, "Desalex“,”Lasvic” etc. grow, sales for Nasonex, Uritos and long-listed products
will decrease mainly due to a decline in the number of prescription. In Generic drugs, sales are expected to rise chiefly reflecting therelease of Mometason AG and Imidafenacin AG.
Although gross profit will decrease due to a fall in net sales, the cost of sales ratio is expected to decline(the cost of sales ratio: down about 0.5%)
Operating income expected to increase thanks to decrease in R&D expenses (¥11.0bln⇒¥10.0bln) and SG&A(excluding R&D）

※The forecast for the fiscal year ending March 31, 2021 announced on May 12,2020 was revised18

Forecast of Mainstay Products Sales（Units：¥billion）

Flutiform(Combination drug for asthma treatment)

Desalex(Antiallergic Agent)

Beova(β3 adrenergic receptor agonist overactive
bladder therapeutics )Lasvic tablets(New quinolone synthetic antibacterial agent)

PentasaNew
ethicaldrugs,etc.
(Japan)(Ulcerative colitis andCrohn’s disease treatment)

Uritos（Kyorin）(Overactive bladder)

Nasonex（Spray type allergic rhinitis remedy）

Kipresfor adult(Leukotriene Receptor Antagonist)for children
Mucodyne（Mucoregulant）

Milton(Disinfectant)

Rubysta(Disinfectant)Montelukast tablets “KM”
(Leukotriene Receptor Antagonist)

Generic
drugs

Mometasone Nasal 50mg
“KYORIN”（Spray type allergic

FY2020FY2019(Revised
forecast)

YoY

ChangeChange(%)

FY2020（Original
forecast）

Versus therevisedforecast

Change

14.6

14.5

－0.1

－0.5

15.0

－0.5

2.6

7.5

＋4.9

＋191.1

8.8

－1.3

4.3

7.3

＋3.0

＋70.6

7.0

＋0.3

1.1

1.7

＋0.6

＋63.8

4.1

－2.4

13.3

12.5

－0.8

－6.1

11.7

＋0.8

5.8

2.2

－3.6

－61.1

2.7

－0.5

6.0

2.4

－3.6

－59.6

2.6

－0.2

5.3

3.8

－1.5

－26.5

4.2

－0.4

6.5

4.3

－2.2

－32.7

5.3

－1.0

5.8

3.3

－2.5

－41.1

4.9

－1.6

2.4

2.3

－0.1

－2.1

2.2

＋0.1

1.5

2.1

＋0.6

＋45.6

1.4

＋0.7

11.5

10.2

－1.3

－10.9

10.7

－0.5

2.8

3.5

＋0.7

＋26.5

3.5

０

－

0.8

＋0.8

－

1.0

－0.2

rhinitis remedy）

Imidafenacin tablets & OD
“KYORIN”(Overactive bladder)※The forecasts for the fiscal year ending March 31, 2021 announced on May 12,2020 are revised

19

Shareholder Returns
Basic Policy
・While maintaining the sound financial base, we aim to improve the capitalefficacy through growth investment and returns to shareholders
・We will maintain stable dividends taking DOE(Dividend On Equity ratio) into
account.

Dividend

Dividend per
Share

FY2018FY2019FY2020（forecast）

¥75

¥75

¥75

（Interim ¥30）

（Interim ¥30）

（Interim ¥30）

※ There is no change in the dividend forecast (¥75/year) announced on May 12, 2020.

◆ The interim dividend of ¥30 was resolved by the Board of Directors on November 5th20

Status of R&D Pipeline21Drug Development Pipeline
Schedule in FY2020 (As of May 12 announcement)

PhⅠ

Development Code

PhⅢ

Application

Approval/
LaunchEnd of the PhⅠ／PhⅡ

Ad-SGE-REIC
Respiratory

PhⅡ
PhⅡStart 2018/6

KRP-108P

2019/7

Expectedlaunch in
FY 2020

Expectedclinical trial
in FY 2020

KRP-R120
Infection

KRP-AM1977Y

2019/10

Expectedlaunch in
FY 2020

Urology

KRP-116D

2020/3

Expectedlaunch in
FY 2020※MK-7264 a drug for chronic coughing : MSD：PhⅢ
understanding for sales collaboration.（2019/5）

Concluded a momorandum of【Licensing development】
Development CodeFPR2 agonist
program
KRP-203

LicenseeDevelopment
Stage

Characteristics

BMS

PhⅠ

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

Under Licensing
activity

PhⅠ

Sphingosine-1-Phosphate Receptor Agonist
Therapy area: GvHD

22

Drug Development Pipeline
Schedule in 2020
Development CodePhⅡ

KRP-108P

Respiratory

Infection

PhⅠ※Progress in 2020（as of Nov.5）

KRP-R120

Application

Approval/
Launch2019/7

Approved
in June2020/7

KRP-AM1977Y

Urology

PhⅢ

KRP-116D

2019/10

Expectedlaunch in
FY 2020

2020/3

Expectedlaunch in
FY 2020※MK-7264 a drug for chronic coughing : MSD：PhⅢ Concluded a memorandum of understanding for sales collaboration.（2019/5）※Due to difficulty to realize the product profile initially set for the gene therapy agent "Ad-SGE-REIC", we suspended its development.

【Licensing development】
Development Code
AKP-009 ※Development CodeFPR2 agonist
programLicenser
ASKA
Pharmaceutical

LicenseeDevelopment StagePhⅡ
Development Stage

Comments
・Novel androgen receptor modulator with the potential to exhibit prostatic
shrinkage and to improve urinary function for Benign Prostatic Hyperplasia
・Joint development and commercialization rights within Japan (Sep.2020)

Comments

BMS

PhⅠ

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

KRP-203※

Priothera

PhⅠ・Sphingosine-1-Phosphate Receptor Agonist
・ Target：AML patients undergoing HSCT・Assignment of intellectual properties and drug substances(Sep.2020)

Compound for Sensorineural
Hearing Loss※

OtonomyNonclinical・「OTO-6XX」 (Otonomy’s Development Code)・License Agreement (Aug.2020)23

Development pipeline aiming for approval in FY2020

Combination drug for asthma treatment “KRP-108Ｐ”■Approved（Jun.2020）
Study results： PhⅢ study confirmed non-inferiority to control drug (fluticasone / salmeterol combination)
Efficacy and safety for patients with bronchial asthma aged ≥ 5, < 16 years confirmed
Disease name ：Bronchial asthma in children
Dosage/Administration：Two inhalations (puffs) of Fultiform (50/5 μg), twice daily

New quinolone synthetic antibacterial agent”KRP-ＡＭ1977Ｙ”

Aim for approval in second half 2020

■Application submitted（Oct.2019）
Study results： PhⅢ study verified efficacy and safety against community-acquired pneumonia, secondary
infections of chronic respiratory lesions etc.
Disease name ： Respiratory tract infection
Dosage/Administration in Ph3 study：
Intravenous administration of 150mg once daily (Double dose on the starting day )Therapeutic agent for interstitial cystitis”KRP-116D”

Aim for approval in second half 2020

■Application submitted（Mar.2020）※Under development for handling unapproved drugs and off-label drugs
Study results：Confirmed the superiority and safety compared to placebo in PhⅢ study※Its superiority compared to placebo proved for the first time worldwide

Disease name：interstitial cystitis※Designated orphan drug

Dosage/Administration in PhⅢ study： one intravesical instillation of 50mL once every two weeks
24Initiatives toward realization of
the long-term vision “HOPE 100”25

Outline of New Medium-Term Business Plan
“HOPE 100-Stage 3-”【Statement】 “Realize growth trend by pursuing Kyorin’s originality”

Business Strategy

Organization
Strategy

Performance Targets

・Shift to business based on the proposal of solutions
and accelerate the growth of new drug groups.
・ Enhance pipeline to support medium-term growth・ Strengthen drug discovery capability to realize thecreation of innovative new drugs.
・ Improve cost competitiveness・ Expand overseas revenue

・ Aim to be the No. 1 company as Best
worthwhileness place of work

・Growth potential and profitability

・Capital policy and shareholder returns

26

Shift to business based on the proposal of solutions and accelerate the growth of new drug groups

Solution Provision Activities in Infection Domain
Response to changing environment（MR activities/Medical care provision system）

・KRP－AM1977Y（Injection）

Rebuild sales structure and enhance details

Shift to business based on
proposal of solutions

Aim for launch in FY2020

Treatment

治療

Lasvic Tablets
Baccidal

ソリューション

Aim for release in FY2020
・New reagent for COVID-19(early Dec.)
・Reagents for RUO (respiratory andsexually transmitted diseases)

Contribution to infection
control in medical institutions
Doctors/Pharmacists/
NursesPrevention

ICT/AST*

MiltonRubystaDiagnosis
GeneSoC・GeneSoC

Total Information Provision* ICT: Infection Control Team
AST: Antimicrobial Stewardship Team

Establish a group-wide sales structure to make
Kyorin’s unique contribution to health care workers.

27

Enhance pipeline to support medium-term growthInterstitial lung disease “KRP-R120”
Clinical trial of KRP-R120（Started Ph1 study）■Contract：license to develop and commercialize in Japan with aTyr pharma (USA)（Jan.2020）■Development status：Ph1 study（started in Jul.2020）■Therapy area：Interstitial lung disease（pulmonary sarcoidosis etc.）※ Developing as a therapeutic drug for rare diseases with low treatment satisfaction■Mode of action
Suppress the excessive activation of immune cells by binding to Neuropilin-2
receptor ※Aim for first-in-class launch■Characteristics
A fusion protein comprised of the immuno-modulatory domain of histidyl tRNA
synthetase fused to the FC region of a human antibody, is a selective modulator of
Neuropilin-2 that downregulates the innate and adaptive immune response ininflammatory disease states.
By making a fusion protein drug, the blood stability of the protein can be
improved and it became possible to extend the half-life※ In USA, aTyr is conducting a P1b / 2a clinical trial for pulmonary sarcoidosis
28

Enhance pipeline to support medium-term growth

Treatment agent for BPH “AKP-009”
Joint Development and Commercialization Agreement for a treatment
agent for Benign Prostatic Hyperplasia with ASKA Pharmaceutical■Contract：Sep.2020（Press release 30/Sep)■Contract contents
・ We were granted the joint development and commercialization rights within Japan＜Contract terms＞
・ Development will be jointly carried out by both companies
・KYORIN makes an upfront and milestone payments according to its progress fromdevelopment to launch

AKP-009（Novel androgen receptor modulator）＜Development Concept＞
Potential to exhibit prostatic shrinkage and to improve urinary function for Benign Prostatic Hyperplasia

Development status⚫Ph2a study （Conducted by ASKA Pharmaceutical, Started in Dec.2019）
Study：Randomized, double-blind, parallel-group comparative study with placebo as a control
Disease name ： Benign Prostatic Hyperplasia（ Scheduled indications: Dysuria associated with benign prostatic hyperplasia）【Primary endpoint】 Safety & efficacy
Rate of change from baseline in prostate volume at 12 weeks of administration
29

Expand overseas revenue

Active partnering activities
License agreement with Otonomy,Inc.(USA) regarding novel candidate compound■Mode of action
It helps improve hearing function in patients with sensorineural hearing loss by regeneratingcochlear hair cells to replace cells damaged due to noise exposure or aging■License agreement
KYORIN granted Otonomy a global exclusive license to develop, manufacture andcommercialize the therapeutic agent（Aug.2020）＜Agreement terms＞
・Eligible to receive up-front payment and milestone payments from development to launch・Eligible to receive royalties and sales milestone payments based on net sales■Otonomy
The company pioneered the application of drug delivery technology to the ear in order todevelop products that achieve sustained drug exposure from a single local administration.
Assignment of Intellectual Properties and drug substances regarding Immunomodulator
KRP-203 to Priothera■Mode of Action Sphingosine-1-Phosphate Receptor Agonist■ Asset purchase agreement in Sep.2020＜Agreement terms＞
・Assignment of the KRP-203 assets such as intellectual rights and drug substance fordevelopment and sales
・Kyorin receives considerations including ordinary shares issued by Priothera■ Priothera
Drug discovery venture company with strengths in developing sphingosine 1 phosphate
receptor30

31