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
- Q2 FY12/24 Financial Results
- Progress of Business in FY12/24
- 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
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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 | ||||||
Copyright D. Western Therapeutics Institute, Inc. All Rights Reserved. | 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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2. Progress of Business in FY12/24
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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 | |||||||||||||||||||
All Rights Reserved. | |||||||||||||||||||
Copyright D. Western Therapeutics Institute, Inc. |
