Interim Term Financial Results Ended
September 2022

November 10 , 2022
KYORIN Holdings, Inc.
Representative Director, President and Chief Executive Officer

Yutaka Ogihara

Outline of Consolidated Financial Results
Trends of mainstay products, generic productConsolidated Financial Forecast
Status of R&D Pipeline
Initiatives toward realizationof the long-term vision “HOPE 100”2Outline of Consolidated Financial Results3

Breakdown of Gain and Loss FY2022 2Q（Units: ¥billion）

FY2021 2Q(Apr-Sep)

FY20222Q (Apr-Sep)

49.1

49.1

New ethical drugs,
etc. (Japan)

33.3

New ethical drugs(Overseas)
Generic drugs

Vs forecast (announced

Year-on-year
Change (%)

Change

0

－0.0

－0.5

32.7

－0.6

－1.9

－0.7

0.3

0.3

0

－8.6

0

15.5

16.1

＋0.6

＋4.2

＋0.3

Cost of sales

26.7

27.5

＋0.8

+2.8

－

SG&A
(R&D)

22.4

20.8

－1.6

－7.2

－

(4.5)

(＋0.1)

Operatingprofit－0.1

0.8

Ordinary
profit0.3

Profit attributable to owners ofparent0.1

Net Sales(4.4)

Changeon May 11, 2021)(+3.1)

(0)

＋0.9

－

+0.1

1.2

＋0.9

+309.8

+0.2

1.2

＋1.1

+921.1+0.5

4Highlights of Business Performance (1/3) YoY: Net Sales(Units: ¥billion)
50.0

49.1

【Net sales ±0 bln】

49.1

New ethical drugs, etc. (Japan) : sales deceased ―0.6 bln
40.0

15.5
0.3

16.1
0.3

●New drugs (Dezalex, Beova, Lasvic) grew
●Decrease in sales of long-listed products (Kipres etc.) and out-

licensing product etc.
●Impact of NHI drug price revision(KYORIN Pharmaceutical : 8% range）

30.0

New ethical drugs (Overseas): sales remained flat

20.0

33.3

32.7

10.0

Generic drugs: sales increased+ 0.6 bln

●Sales increase in Kipres AG etc.
●New generic drugs launched in June contributed to
0.0

sales
FY 2021 2Q

FY 2022 2Q

5

Highlights of Business Performance (2/ 3) YoY: Operating Profit(Units: ¥billion)
1【Operation profit ＋0.9 bln】
Gross profit decreased

ー0.8 bln

Net sales: remain flat
0.5

0.8

0

-1.8
-0.1

R&D expenses increased

-0.8

-0.5

Cost of sales: +1.6 percentage point<Reason of decrease>
Increase in sales of main product<Reasons of increase>
Impact of NHI drug price revisions (Kyorin
Pharmaceutical: 8% range)
Increase in sales of generic drugs+0.1 bln¥4.4 bln （2Q FY2021）⇒ ¥4.5 bln （2Q FY2022)

SG&A (excluding R&D) decreased －1.8 bln

＋0.1

-1

Operatingprofit2Q FY2021

GrossprofitR&D
expenses

SG&A(excluding R&D)

Operatingprofit2Q FY2022¥18.1 bln (2Q FY 2021) ⇒ ¥16.3bln (2Q FY2022)
Decrease in license fees etc.
(Decline of upfront payment posted in FY2021 andpayment of royalty)

Highlights of Business Performance (3/3) vs Forecast（Units: ¥billion）

vs forecast

Year-on-year

FY2021 2Q

FY2022 2Q(Apr-Sep)(Apr-Sep)

Change49.1

49.1

New ethical drugs,
etc. (Japan)

33.3

New ethical drugs(Overseas)
Generic drugs(announced on May 11, 2022)

Change (%)

Change

0

－0.0

－0.5

32.7

－0.6

－1.9

－0.7

0.3

0.3

0

－8.6

0

15.5

16.1

+0.6

+4.2

+0.3

Cost of sales

26.7

27.5

+0.8

+2.8

－

SG&A
(R&D)

22.4

20.8

－1.6

－7.2

－

(4.4)

(4.5)

(+0.1)(+3.1)(0)

Operating profit

－0.1

0.8

+0.9

－

+0.1

Ordinary profit

0.3

1.2

+0.9

+309.8+0.2

Profit attributable to owners ofparent

0.1

1.2

+1.1

+921.1+0.5

Net Sales【Difference from original Forecast (Announce on May 11, 2022)】
Net sales: Sales of new ethical drugs etc. (Japan) was lower than forecast and sales of generic drugs, mainly of AG exceeded forecast.
Operating profit: Gross profit was lower than forecast owing to less than expected sales in new ethical drugs etc. (Japan). On the other hand, operating profit
was roughly in line with forecast owing to being lower then forecast for SG&A expenses (excluding R&D expenses) .
Profit: Extraordinary profit of ¥1,319 mln (gain on insurance of ¥881 mln, income of compensation for damages of ¥393 mln, regarding a fire at Nishinihon
delivery center)
Extraordinary loss of ¥678 mln (Impairment losses of ¥101 mln, provision for loss on liquidation of subsidiaries and associates of ¥561mln regarding
dissolution of ActivX)7

FY2022 2Q Main Product Sales Update（Units: ¥billion）

FY2022 2Q(Apr-Sep)(Apr-Sep)

ChangeChange (%)

Change

6.3

5.7

－0.6

－8.9

＋0.1

2.6

3.0

＋0.4

＋14.9

＋0.1

4.3

5.5

＋1.2

＋26.6

－0.9

0.8

1.0

＋0.2

＋17.1

－0.3

－

0.1

＋0.1

－

－0.1

7.1

6.5

－0.6

－8.0

＋0.2

3.6

2.7

－0.9

－23.9

－0.1

Mucodyne

1.6

1.5

－0.1

－5.1

＋0.1

Nasonex

0.7

0.6

－0.1

－9.8

＋0.1

0.7

0.4

－0.3

－44.5

＋0.1

1.0

1.0

0

＋0.0

0

1.0

1.1

＋0.1

＋2.7

＋0.1

5.1

5.4

＋0.3

＋5.4

+0.8

1.0

1.1

＋0.1

＋7.0

+0.1

0.4

0.4

0

－7.1

+0.2

Flutiform(Combination drug for asthma treatment)

Desalex(Antiallergic Agent)

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

Lyfnua(selective P2X3 receptor antagonist / chronic cough)New
ethicaldrugs, etc.
(Japan)Pentasa(Ulcerative colitis and Crohn’s disease treatment)

Kipres(Leukotriene Receptor Antagonist)（Mucoregulant）（Spray type allergic rhinitis remedy）

Uritos (KYORIN)(Overactive bladder))Milton(Disinfectant)

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

Genericdrugs

vs Forecast

Year-on-year

FY2021 2Q

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

Imidafenacin tablets & OD“KYORIN”(Overactive bladder)(announced on May 22, 2022)

Trends of Mainstay Products and Generic Drugs

9

Flutiform（Anti-asthmatic）
ICS/LABA market（Units: ¥billion）(Apr-Sep)（Units: %）

60.0

20

15.2
40.0

Sales

Flutiform share

11.9
56.7

15.8

（Units: ¥billion）

15

14.6
13.1

15.8
15

12.6

10

60.8

Second halfFirst half

7.0

7.9

13.3

12.6

6.9

6.3

6.4

6.3

10

51.1

20.0

45.7

41.8

12.0

6.3

5
5

6.1

6.7

5.7

5.6
(Forecast)

0.0

0
19/3

20/3

21/3

22/3

23/3

0
19/3

20/3

21/3

22/3

ICS/LABA market: Shrink 8.6%
¥45.7 bln (Apr-Sep 2021)⇒ ¥41.8 bln (Apr-Sep 2022)*1● Impact of NHI drug price revision and expansion of triple therapy

Share of Flutiform sales
15.8% (Apr-Sep 2021)⇒ 15.8% (Apr-Sep 2022) *1
Rate of NHI drug price revision for Flutiform aerosol: – 6.97% (compared with Apr
2021)

Medium to long-term market outlook

23/3(Forecast)

Copyright © 2022 IQVIA. JPM Calculated based on Mar 2018-2022 (Apr-Sep) Reprinted with permission

Status in FY 2022 2Q●Appeal the utility of aerosol formulations to suitable for patient with weak respiration●Penetrate pediatric indications and increase market share●Information activity accreting to “Practical guideline for Asthma management”

Effort for FY 2022
● Appeal the utility of aerosol formulations● Penetrate pediatric indications and increase market share● Increase market share (quantity basis)

Shrinking market due to NHI drug price revision and launch generic drug
*1 Copyright © 2022 IQVIA. JPM Calculated based on Apr-Sep 2021, Apr-Sep 2022 Reprinted with permission
10

Desalex (Antiallergic Agent)
Antihistamine market (Apr-Sep)

Sales

New drugs（Units: ¥billion）

Desalex share

80.0

10.0

Second halfFirst half

（Units: ¥billion）

10

9.0

7.4
60.0

5.2
40.0

6.0

68.4

66.1

4.1
58.7

4.0

52.3

6
4

3.0

0.0

0.0
21/3

5.7
5.0

22/3

23/3

4.5

3.7
3.9

0.9

2.6

2.8

2.6
0.0

1.8

19/3

20/3

21/3

2

1.0

0.0
20/3

7.1
Supplysuspended :about 10 months

5.0

2.0

19/3

8.0

8

7.0

5.9

55.9
20.0

8.0

0

2.6

3.0

22/3

23/3
(Forecast)

Copyright © 2022 IQVIA. JPM Calculated based on Mar 2018-2022 (Apr-Sep) Reprinted with permission

Antihistamine Market: Shrink 6.4%
¥55.9 bln(Apr-Sep 2021) ⇒ ¥52.3 bln(Apr-Sep 2022)*1●Shrinking market due to NHI drug price revision and launch generic drug

Share of Desalex sales
5.9% (Apr-Sep 2021) ⇒ 7.4% (Apr-Sep 2022)* 1●Dec 2018 single month：6.3%*2（Before supply suspension)●Sep 2022 single month: 7.5%*2[Rate of NHI drug price revision: –9.62% (compared with Apr 2021)

2.9(Forecast)Status in FY 2022 2Q●Prescription in otolaryngology: No.2
●Focus on acquiring prescriptions in internal medicine●Enhancement of corroboration with KAKEN in dermatology

Effort for FY 2022
●Aim to be first line treatment as effective and usability drug
Usability: less sleepiness, no-limitation for drive, administration with or without meals●Aim to be No.1 prescription in otolaryngology

Medium to long-term market outlook
Shrinking market due to NHI drug price revision and launch generic drug
*1: Copyright © 2022 IQVIA. JPM Calculated based on Apr-Sep 2021, Apr-Sep 2022 Reprinted with permission*2: Copyright © 2022 IQVIA. JPM Calculated based on Dec 2018 single month, Sep 2022 single month Reprinted with permission

11

Beova (OAB)
OAB market (Apr-Sep)

Sales（Units: ¥billion）（Units: ¥billion）

Beova(KYORIN) share

(%)

20

50

40

48.5
30

44.3

46.6

8.9

47.3

15

9.2

20

0
20/3

21/3

22/3

14.1

10

23/3

8.6

10
4.3

5

0

8.6

7.3
3.5

4.3

6.4

5

1.8

19/3

15

14.8

43.8

10

Second halfFirst half

0.7
0

3.7

0.7

0.6

19/3

20/3

3.8

4.3

21/3

22/3

5.5

(Forecast)

23/3(Forecast)

Copyright © 2022 IQVIA. JPM Calculated based on 2018-2022 Apr-Sep Reprinted with permission

OAB market: Shrink 7.4%

¥47.3bln (Apr-Sep 2021）⇒ ¥43.8bln (Apr-Sep 2022）*● Market shrink due to impact of NHI drug price revision and launch for generic drugMarket expansion β3 adrenergic receptor (+8.3％)
Share of Beova (KYORIN) sales: Expand 1.6%

9.2% (Apr-Sep 2021）⇒ 14.8% (Apr-Sep 2022)*
Rate of NHI drug price revision: –4.57% (compared with Apr 2021)

Status in FY2022 2Q● End of restrictions on shipment in August 1, 2022
● Focus on providing information● Provide information in urology with Zymso

Effort for FY2022● Aim to establish evaluation of Beova as first line treatment for OAB

Medium to long-term market outlook
Shrinking market due to NHI drug price revision and launch generic drugMarket expansion for β3 adrenergic receptor* Copyright © 2022 IQVIA. JPM Calculated based on Mar 2021 MAT, Mar 2022 MAT Reprinted with permission

12

End of restrictions on shipment

End of Restrictions on Shipment: August 2022
Statue of Beova in market of OAB● Number of new costumers expand as our plan
● Achieved No.1*1 for rate of acquiring prescriptions in new patients● Expansion of market share for forecast sales proceed as expected
Decrease in sale forecast (2Q)

Forecast: 6.4bln yen Actual: 5.5bln yen

In consideration of the recent issue for stable supplies, we expected to have mass order frommedical institute and wholesalers after endo of restrictions on shipment. However they havemuch more inventory than expected, so that the sales was decline than forecast
Market share of Beova in OAB［Target in FY 2022: 18％］
Mar 2022 (single month)：11.9％ ▶ Sept 2022 (single month) ：16.4% *2

Aim to No.1 in Market of OAB*1 Copyright © 2022 IQVIA IQVIA. Rx Sep 2022, Reprinted with permission*2 Copyright © 2022 IQVIA. JPM Mar/Sep single month 2022, Reprinted with permission

13

Lasvic (New quinolone synthetic antibacterial agent)
Oral antimicrobial market(Apr-Sep)

Lasvic share（Units: ¥billion）

Sales
5

3.3
40.0

2.7

48.7

20.0

31.3
1.4

28.9

1.8
1.1

2

1

0
21/3

2

1

0.0
20/3

3

4

3

30.7

19/3

3.0

(%)

60.0

50.4

Second halfFirst half

22/3

23/3

0.9

1.1

0.7

20/3

21/3

1.0
0.8

¥31.3bln (Apr-Sep 2021）⇒ ¥28.9bln (Apr-Sep 2022）*●Reducing the number of patients due to infection prevention measure result toshrink market.

1.0

0.2

0

22/3

1.3
(Forecast)

23/3(Forecast)

Copyright © 2022 IQVIA. JPM Calculated based on 2018-2022 Apr-Sep Reprinted with permission

Oral antimicrobial market: Shrink 7.6%

2.0

Status in FY2022 2Q● Expand prescriptions in old people/patients with disease

Effort for FY2022
Share of Lasvic sales:
2.7% (Apr-Sep 2021）⇒ 3.3% (Apr-Sep 2022)*
Rate of NHI drug price revision: –3.18% (compared with Apr 2021)
Medium to long-term market outlook⚫ Aim to be first line treatment for old people/patients with disease⚫ Targeting to provide information⚫ Clarify target disease/medical case to provid information

Expect to tend to remain flat in oral antimicrobial due to NHI drug price revision andprevent infection/appropriate use against AMR* Copyright © 2022IQVIA. JPM Calculated based on Apr-Sep 2021, Apr-Sep 2022 Reprinted with permission

15

Status of Generic Drugs
Sales in GE

Second halfFirst half

Sales in AG (three products) among with the sales at left

（Units: ¥billion）

40

30

20

29.3

15.7

31.0

32.2

34.8

36.7

20

14.3

15

16.8

17.8

19.3

20.6

14.2

14.4

15.5

15.8

16.6
14.8
10.1

8.5

9.7

5.3

5.8

5.7

6.5

19/3

20/3

21/3

22/3

6.6

13.6

15.4

11.9
10

10

Second halfFirst half

7.9

5

16.1 (Forecast)

6.9

5.8
(Forecast)

0

0
19/3

20/3

21/3

22/3

23/3
(Forecast)Status in FY2022 2Q

Effort for FY2022● Montelukast AG, Mometasone AG, Imidafenacin AG maintain the● Expand sales of strategic products

market share of more than 50% in the GE market● Released in June 2022: 2 ingredients 5 items○Febuxostat tablets 10mg/20mg/40mg● Steady launch for new products and sales growth○Duloxetine Capsules 20mg/30mg

23/3(Forecast)Released in December 2022: 2 ingredients 3 items○Ramelteon Tablets 8mg○Esomeprazole Capsules 10mg/20mg● Promotion of AG strategy

Aim to maintain market share of more than 50% for AG productsin the GE market

15

Consolidated Financial Forecast FY2022

16

Consolidated Financial Forecast FY2022(Unit: ¥billion)

FY2021

FY2022105.5
New ethical drugs,
etc. (Japan)

Year-on-year
ChangeChange (%)

112.0

+6.5

+6.1

69.7

74.5

+4.8

+6.8

New ethical drugs(Overseas)

1.0

0.7

－0.3

－32.2

Generic drugs

34.8

36.7

+1.9

+5.5

Cost of
sales

56.1

-

-

-

SG&A
(R&D)

44.4

-

-

-

(8.9)

(10.9)(+2.0)(+22.5)

Operatingprofit

5.0

5.5

+0.5

+9.8

Ordinary
profit

5.6

6.0

+0.4

+7.7

Profit attributable to ownersof parent

3.9

4.5

+0.6

+14.4

Net Sales※The results forecasts for the full year announced on May 11, 2022 remain unchanged【Key factors for Increase/decrease (Year-on-Year)】Net sales : The sales of new ethical drugs (Japan) are expected to increase due to expansion in sales of new drugs by end of shipping adjustment in August 2022.
For GE, AG and new products launched in FY2022 expected to contribute in sales increase.
Operating profit: Gross profit increased although impact on NIH drug price revisions. Operating profit are expected to increase according to decrease SG&A
expenses (excluding R&D expenses) but R&D expenses are increased.
Cost of sales ratio: Increase about 0.5 percentage points SG&A expenses(excluding R&D expenses): decrease about 2 percentage points
17

Forecast of Mainstay Products Sales

Flutiform(Combination drug for asthma treatment)

Desalex(Antiallergic Agent)

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

Lyfnua(Selective P2X3 receptor antagonist/chronic cough)New ethicaldrugs, etc.
(Japan)Pentasa(Ulcerative colitis and Crohn’s disease treatment)

Kipres(Leukotriene Receptor Antagonist)

Mucodyne（Mucoregulant）

Nasonex（Spray type allergic rhinitis remedy）

Uritos (KYORIN)(Overactive bladder))Milton(Disinfectant)

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

Generic
drugs

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

Imidafenacin tablets & OD“KYORIN”(Overactive bladder)(Unit: ¥billion)

Year-on-year

FY2021

FY2022(Forecast)

ChangeChange (%)

12.6

12.0

－0.6

－4.6

7.1

8.0

+0.9

+13.6

8.6

14.1

+5.5

+64.4

1.8

3.0

+1.2

+65.8

-

0.5

+0.5

-

14.0

12.5

－1.5

－9.9

8.4

6.8

－1.6

－18.5

3.5

2.9

－0.6

－14.1

2.4

1.8

－0.6

－23.3

1.3

0.7

－0.6

－40.4

2.1

2.0

－0.1

+0.4

2.1

2.0

－0.1

－0.1

12.2

10.7

－1.5

－11.7

3.6

3.6

0

+0.1

0.8

0.5

－0.3

－26.3

※The results forecasts for the full year announced on May 11, 2022 remain unchanged18

Shareholders Returns

Capital
Policy● While maintaining the sound financial base, we aim to improve the capitalefficiency through growth investment and returns to shareholders● We will maintain stable dividends taking DOE (Dividend on Equity ratio)
into account

Dividend

Dividend pershare (Yen)FY2022

FY2020

FY2021

¥75

¥52

¥52

(Interim ¥30)

(Interim ¥20)

(Interim ¥20)

(Forecast)※The year-end dividend of 52 yen remain unchanged in the fiscal year ended March 2023

〇The year-half dividend of 20 yen have been decided at in the Board Meeting scheduled in November 9, 2022

19

Status of R&D Pipeline

20Plan of R&D Pipeline in FY2022
As of May 11, 2022

Development code

Ph1

Ph2

Ph3

Application

Launched

Lyfnua tablets
Respiratory(Apr 2022)

KRP-R120

Infections

KRP-A218

Urology

AKP-009※2

Approval/Launch

Planning for initiating MRCT ※1（April 2021)

Plan in FY2022※1 MRCT: Multi-Regional Clinical Trials※2 Additional Ph1 study to confirm the maximum effect at a higher dose has been completed (ASKA)［Licensed Compound］
Compound/CodeKRP-203

LicenseePriothera

Stage

Ph1

Features⚫Sphingosine-1-Phosphate receptor Agonist⚫Target: AML patients undergoing HSCT
⚫Assignment of IP and drug substances (Sep. 2020)□Compound for sensorineural healing loss was removed from the list since Otonomy (licensee) decided to discontinue the program for strategic reasons21

Status of R&D Pipeline in FY2022
As of Nov 9, 2022

Development code

Ph1

Ph2

Ph3

Application

Launched

Lyfnua tablets(Apr 2022)

Respiratory
Sep 2022

KRP-R120※1
Infections

Urology

KRP-A218

AKP-009

Approval/Launch（April 2021)※2

KRP-114VPAug 2022※1 Ph1b/2a study has been completed in USA (aTyr)※2 Additional Ph1 study to confirm the maximum effect at a higher dose has been completed (ASKA)［Licensed Compound］
Compound/CodeKRP-203

LicenseePriothera

Stage

Ph1

Features⚫Sphingosine-1-Phosphate receptor Agonist⚫Target: AML patients undergoing HSCT
⚫Assignment of IP and drug substances (Sep. 2020)22

Pulmonary Sarcoidosis treatment [KRP-R120(Efzoﬁtimod)]●Multi-Regional Clinical Trials (Phase 3 study)
Titles

Efficacy and Safety of Intravenous Efzofitimod in Patients With Pulmonary
Sarcoidosis

Study Design

Randomized, Double-Blind, Placebo-Controlled Parallel Assignment Study

Outcome
Measures[Primary Outcome Measures]
Change from baseline in mean daily oral corticosteroid (OCS) dose post-taper[Secondary Outcome Measures]• Annual rate of change in absolute value of Forced vital capacity (FVC)• Percent change from baseline in mean daily OCS dose post-taper• Change from baseline in King's Sarcoidosis Questionnaire (KSQ)-Lung score

Estimated Enrollment

264

23

GMAC（Genetically Modiﬁed Adipocyte)
StatusPatients

Joint development and license agreementwith CellGenTech (June 2022)
Non-clinilcal study is ongoing
Target disease

Fabry disease

1.Excision of
Subcutaneous
adipose tissue

Patients

2.Isolation of
Adipocytes

5.Administration of GMAC

3.GMAC Preparation/Gene transfer

4.Expansion culture of GMAC
Protein, enzyme

6.Supplement oftherapeuticprotein/enzyme

Feature⚫ GMAC is the genetically modified human adipocytes with an ability to produce enzyme or protein fortreatment in patients⚫ Adipocytes have a high ability of protein secretion, a long life span and a low risk of tumorigenesis⚫ Possibility of supplement insufficient enzyme over years by one dose (Contribution to improving QOL)
<Fabry disease>○ Progressive hereditary disorder which occurred due to gene mutation in the gene encoding a-galactocidase, a typeof lysosome hydrolase○ Current treatment: Enzyme replacement therapy (Intravenous infusion once every two weeks○ Estimated patients in Japan: approx. 1700

Challenge to New Modality ・ Aim to Earlier Commencement of Clinical Trial
24

Initiative toward Realization of the Long-term Vision “HOPE 100”25

Overview of Medium-Term Business Plan “HOPE 100-Stage 3-”

Statement

Realize growth trend by
pursuing Kyorin’s originality

Business
Strategy● Shift to business based on the proposal of solutions andaccelerate the growth of new drug groups● Enhance pipeline to support medium-term growth● Strengthen drug discovery capability to realize the creation of
innovative new drugs● Improve cost competitiveness● Expand overseas revenue

Organization
Strategy● Aim to be the No. 1 company for career fulfillment

Performance
Targets● Growth potential and profitability● Capital policy and shareholder returns

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

Solution Provision Activities in Infection Domain“Lasvic tablets“”Lasvic IV Drip Infusion Kit ”
・Contribute to respiratory and ENT infection along with tablets“KRP-A218”(Rhinovirus): Ph1
・Expand pipeline in infection medicines

Oral antiviral drug “LAGEVRIO” (2022.1-)
Contribution to treatment for Covid-19 by
Co-promotion with MSD.K.K.

Treatment

治療
LasvicTablets/Injection
ソリューション
Baccidal Tabletsetc.

GeneSoC

Doctors/Pharmacists/Nurses

ICT/AST*
Contribution to
infection control in
medical institutions

Diagnosis

Prevention

GeneSoC
Reagent for COVID-19,
Reagent for RUO

MiltonRubystaetc.

“PCR pre-treatment kit”
”GeneSoc mini”“SARS-CoV-2 N2 detection kit”
“Influenza virus A/B detectionkit” (2022.11)
Aim to development/sales of newlaboratory reagents and IVD
product in respiratory andsexually transmitted infections

・GeneSoC* ICT: Infection Control Team
AST: Antimicrobial Stewardship Team

Infection-related
product sales

FY 2 0 2 0¥5.8bln

FY 2 0 2 1¥7.2bln

FY 2 0 2 3¥8.9bln (Forecast)¥4.1bln (2Q Actual)27

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

Accelerate the growth of new drug groups

Treatment of chronic coughLyfnua Tablets 45 mg

Launch: April 21, 2022

Status in FY2022 2Q⚫ Enhancement of better understanding for product characteristic to respiratory specialists⚫ Acceptance of product in university hospitals or core hospitals progress as planed

Plan in FY2022⚫ Clarification for positioning of product• Enhancement of better understanding for product characteristic to respiratory specialists• Aim to increase number of prescribing physicians in university hospitals or core hospitals

Aim to establish a position for the only drug which has indication
for refractory chronic cough28

Enhance pipeline to support medium-term growth

Development of Digital Therapeutics in Otolaryngology Field

Background

Expand product portfolio including new treatment option for strengthen
competitiveness in otolaryngology area, aiming "Establish strong
presence in priority area (respiratory, otolaryngology and urology)”※illustrative purpose

Purpose● Challenge to unmet medical needs
Patient satisfaction with treatment inotolaryngology is low● New treatment options to patients

Service regarding digital x healthcare/medical care are attachingattention
Health care system for digital healthcare are being established

Collaboration Research and Sales Agreement for development of Digital Therapeutics（November 2022)

SUSMED

Know-how of clinical development for DTx, negotiation
experience with PMDA and success clinical trial of digital
therapeutics for insomnia

KYORIN

Knowledge and know-how of clinicaldevelopment, human network in
otolaryngology field

Provide New Treatment Options to Patients in Otolaryngology
29Improve cost competitiveness

Reform Cost Structure by Group Optimization

Start of Construction of the Takaoka New Plant
Strengthen the supply capacity as the production of drugs increased【Outline of the Takaoka Plant】
Location

IC Park 8, Takaoka-City, Toyama

Site Area

42,457 m2

Building

Three floors, Building area about 7,262 m2,
Total floor area about 21,091 m2

Groundbreaking

September 2022

Completion

October 2023 (Scheduled)

Operation

April 2024 (Scheduled)

Investment

About 10 billion yen

前倒しで達成⚫ Production function of 20年度
Inami which manufactures
GE are transferred to Takaoka⚫ Product capacity of approximately two billion tablets (More than twice of Inami Plant)⚫ Significantly reduce CO2 emissions, actively utilize LNG and renewable energy
Building Production System Supplies Stably and at Low Cost
30

Business strategy in FY 2022

Increase the “Speed”

31

Disclaimer

This material contains performance forecasts, goals and plans, and other forward-looking statements
related to the Group. These statements are based on the judgment of the Group’s assumptions andoutlooks based on the information and forecasts available at the time of preparation of this material,and contain known or unknown risks and uncertainties. Therefore, due to various factors that may occur,
the actual performance, progress / success / failure of the development and other insights may differ
significantly from the description. It also contains information about medicines (including those underdevelopment), but the description is not for the purpose of advertising or medical advice.

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