D.western Therapeutics Institute, Inc.TSE: 4576

Q2 FY12/24 Financial Results Briefing Materials

· Issued by D.western Therapeutics Institute, Inc.

Note:This document has been translated from the Japanese original for reference purposes only. In the event of any discrepancy between this translated document and the Japanese original, the original shall prevail.

Q2 FY12/24

Financial Results Briefing Materials

August 9, 2024

D. Western Therapeutics Institute, Inc.

Stock Code: 4576

Copyright D. Western Therapeutics Institute, Inc. All Rights Reserved.

Table of Contents

  1. Q2 FY12/24 Financial Results
  2. Progress of Business in FY12/24
  3. FY12/24 Forecast

(Reference) Business Overview

Copyright D. Western Therapeutics Institute, Inc. All Rights Reserved.

2

1. Q2 FY12/24 Financial Results

January 1 - June 30, 2024

Copyright D. Western Therapeutics Institute, Inc. All Rights Reserved.

3

Consolidated Statement of Income (vs. full-year forecast)

(JPYmn)

FY 12/23

FY 12/24

1H results

FY results

1H results

YOY

FY forecast

Progress

Primary factors

change

(out Feb.13)

Net sales

187

428

223

35

400

55.9% •

Storong royalties for DW-1002 and

GLANATEC FAMILY

SG&A expenses

431

1,190

654

223

•

Development expenses for H-1337

R&D expenses

294

930

521

226

1,600

32.6%

was less than expected. It will be

expensed upon completion

Other SG&A

136

259

133

(3)

expenses

Operating loss

(258)

(798)

(449)

(191)

(1,500)

-

Ordinary loss

(254)

(796)

(459)

(204)

(1,510)

-

Loss attributable to

(247)

(812)

(520)

(272)

(1,510)

•

Loss on redemption of convertible

owners of parent for

-

bonds of JPY60mn in extraordinary

the interim period

losses

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5

Consolidated Statement of Income

As of June 30, 2024

(change compared to December 31, 2023)

(JPYmn)

Current liabilities 95(-98)

Cash and deposits

Non-current liabilities

Cash and deposits

  • Declined due mainly to R&D expenditures
  • Funding for immediate business development activities is secured., supported in part by the exercise of Series 12 Stock Acquisition Rights

Supplies

  • JPY260mn increase in advance payments to suppliers due to H-1337 development

Non-current assets

  • JPY20mn in amortization of intangible assets related to the licensing agreement for DW-1002 (Europe)

1,301(-566)

1,113(+214)

Current liabilities

  • JPY112mn decline in accounts payable due to H-1337 and DWR-2206 development costs
  • JPY9mn increase in current portion of long-term borrowings

Non-current liabilities

Accounts

receivable trade 123(+6)

Net assets

Other current

423(+269

)

856(-423)

assets

Non-current

217(-17)

assets

  • JPY160mn increase in long-term borrowings due to loans to fund the development of DWR-2206
  • JPY53mn increase due to difference between issuance of bonds payable of JPY660mn and redemption of convertible bonds of JPY60mn

Net assets

  • Recorded a loss attributable to owners of parent of JPY520mn
  • Recorded JPY45mn each in capital and capital reserves due to exercise of stock acquisition rights

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6

2. Progress of Business in FY12/24

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9

Development Pipeline in 2024 1H

products on market

Region

Current state

GLANATEC

®

(

)

Japan, Asia

Decrease slightly due to launch of compounded drugs

Single drug

GLA-ALPHA

®

(

)

Japan

Launched in December 2022, Strong sales

Combination drug

DW-1002(

Single drug

)

Europe, U.S.

Strong due to yen depreciation

DW-1002(

)

Europe, etc.

Strong due to yen depreciation

Combination drug

Products

Region

Non-clinical

P-I

P-Il

P-Ill

Application

Approval

Current state

K-321

U.S., etc.

Global Phase III ongoing

Combination

U.S.

DW-1002

China

Regulatory review underway

Single

Japan

Negotiations with the regulatory authority and

examination underway for application filing

DW-1001

Japan

H-1337

U.S.

Phase IIb ongoing

DW-5LBT

U.S.

Reapplied in January 2024, received CRL in

July

DWR-2206

Japan

Submitted a Clinical Trial plan Notification for

Phase II in March

10

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