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.
FY12/24
Financial Results Briefing Materials
February 10, 2025
D. Western Therapeutics Institute, Inc.
Stock Code: 4576
Copyright D. Western Therapeutics Institute, Inc. All Rights Reserved.
Table of Contents
- FY12/24 Financial Results
- Progress of Business in FY12/24
- FY12/25 Forecast
(Reference) Business Overview
Copyright D. Western Therapeutics Institute, Inc. All Rights Reserved. | 2 |
1. FY12/24 Financial Results
January 1-December 31, 2024
Copyright D. Western Therapeutics Institute, Inc. All Rights Reserved. | 3 |
Consolidated Statement of Income (YoY comparison)
471 | 1,634 | (JPYmn) | ||||||||||||
1,367 | ||||||||||||||
1,190 | ||||||||||||||
930 | ||||||||||||||
428 | 259 266 | Loss attributable to | ||||||||||||
36 46 | ||||||||||||||
Operating loss | Ordinary loss | owners of parent | ||||||||||||
Net sales | Cost of sales SG&A expenses(R&D expenses) | (Other) | ||||||||||||
(798) | (796) | (812) | ||||||||||||
FY12/23 | FY12/24 | (1,209) | (1,228) | (1,290) | ||||||||||
Net sales
- Despite the loss of domestic royalty income from GLANATEC in September, sales increased 10.1% YoY, reaching the highest level in the last five yearsdue to growth in DW-1002 sales.
- On a standalone basis, DW-1002 sales increased 21.0% YoYdue to an increase in volume and the impact of a weaker yen. GLA-ALPHA also grew steadily, increasing 74.9% YoY.
R&D expenses
- R&D expenses rose 47.0% YoYdue to increased spending on development of H-1337 (Phase IIb study in the US) and DWR-2206.
Copyright D. Western Therapeutics Institute, Inc. All Rights Reserved. | 4 |
Consolidated Statement of Income (vs. full-year forecast)
(JPYmn) | ||||||||
FY12/23 | FY12/24 | |||||||
FY results | FY forecast | FY results | % of initial | Primary factors | ||||
(out Feb.9) | forecast | |||||||
• Strong royalties for DW-1002 and GLA-ALPHA | ||||||||
428 | 400 | 471 | 17.9％ | • GLANATEC (Japan) ended royalty income in | ||||
Net sales | September, but the impact of the combination | |||||||
drug was minimal, and revenue was | ||||||||
substantial | ||||||||
SG&A expenses | 1,190 | 1,634 | ||||||
R&D expenses | 930 | 1,600 | 1,367 | △14.5％ | • | No payment milestone for DW-5LBT | ||
• | Development expenses for H-1337 was less | |||||||
than expected. | ||||||||
Other SG&A | 259 | 266 | • | As planned | ||||
expenses | ||||||||
Operating loss | △798 | △1,500 | △1,209 | － | ||||
Ordinary loss | △796 | △1,510 | △1,228 | － | ||||
Loss attributable to | △812 | △1,510 | △1,290 | － | • | Loss on redemption of convertible bonds of | ||
owners of parent | 5 | JPY60mn in extraordinary losses | ||||||
Copyright D. Western Therapeutics Institute, Inc. All Rights Reserved. |
Consolidated Statement of Income
As of December 31, 2024
(change compared to December 31, 2023)
（JPYmn）
Current liabilities
132（-61）
Cash and deposits | Non-current liabilities |
1,126 (-741) | 802（-96） |
Accounts receivable | 125（+7 | ） | ||
trade | Net assets | |||
224（- 70） | ||||
Other current assets | 733（-545） | |||
Non-current | 194（-41） | |||
assets |
Cash and deposits
- Declined due mainly to R&D expenditures
- Increase due to the exercise of the 12th series of stock acquisition rights
Supplies
- Increase in advances paid for the development of H-1337 and DWR-2206, increase in uncollected consumption tax
Non-current assets
- JPY41mn in amortization of intangible assets related to the licensing agreement for DW-1002 (Europe)
Current liabilities
- JPY76mn 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
- Redemption of convertible bonds of JPY606mn from the issuance of corporate bonds of JPY660mn and redemption of corporate bonds of JPY357mn through the exercise of stock acquisition rights
- JPY206mn increase in long-term borrowings due to loans to fund the development of DWR-2206
Net assets
- Recorded a loss attributable to owners of parent of JPY1.2bn
- Recorded JPY371mn each in capital and capital reserves due to exercise of stock acquisition rights
Copyright D. Western Therapeutics Institute, Inc. All Rights Reserved. | 6 |
Consolidated Cash Flow Statement
FY 12/23
2,334 | 134 | 1,867 | ||
(586) | (15) | |||
Year-start | Operating CF | Investment CF | Financing CF | December 31,2023 |
FY 12/24 | （JPYmn） | |||
1,867 | ||||
567 | 1,126 | |||
(1,299) | (10) | |||
Year-start | Operating CF | Investment CF | Financing CF | December 31,2024 |
Cash flow from operating activities
- JPY1.2bn outflow due to the recording of loss before income taxes
Cash flow from investing activities
- JPY9mn outflow from acquisition of property, plant and equipment
Cash flow from financing activities
- JPY710mn proceeds from the exercise of stock acquisition rights, JPY660mn proceeds from issuance of bonds, JPY226mn proceeds from long-term borrowings
- JPY666mn redemption of convertible bonds, JPY357mn redemption of bonds,
On-hand liquidity on December 31, 2024 consisted only of JPY1.1bn in cash and deposits (no securities)
【Exercise status of Series
12 Stock Acquisition Rights】
- Number of shares exercised 9,350,000（71.9％）
- Total amount raised JPY727mn (As of Dec. 31, 2024)
*The exercise was completed on February 7, 2025 (see page 35).
Copyright D. Western Therapeutics Institute, Inc. All Rights Reserved. | 7 |
2. Progress of Business in FY12/24
Copyright D. Western Therapeutics Institute, Inc. All Rights Reserved. | 8 |
Development Pipeline in FY12/24
products on market | Region | Current state | |||||||
GLANATEC | ® | （ | ） | Japan, Asia | Royalty ended in September in Japan | ||||
Single drug | |||||||||
GLA-ALPHA | ® | （ | ） | Japan, Asia | Growth in royalites in Japan, approved in Thailand | ||||
Combination drug | |||||||||
DW-1002（ | ） | Europe, U.S. | Strong due to yen depreciation and volume increase | ||||||
Single drug | |||||||||
DW-1002（ | ） | Europe, etc. | Strong due to yen depreciation and volume increase | ||||||
Combination drug | |||||||||
Products | Region | Current state | |||||||
K-321 | U.S., etc. | Global Phase III ongoing | |||||||
Combination | U.S. | ||||||||
DW-1002 | Single | China | Regulatory review underway | ||||||
Japan | Negotiations with the regulatory authority and examination underway for application filing | ||||||||
DW-1001 | Japan | ||||||||
H-1337 | U.S. | Completion of dosing in the Phase IIb study in August, topline data released in November | |||||||
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, | |||||||
Completion of dosing in December | |||||||||
Copyright D. Western Therapeutics Institute, Inc. All Rights Reserved. | 9 |
Achievement of 2024 event calendar
H-1337 | Publish top-line data of Phase IIb study in US | achieved Good results | ||
DW-5LBT | U.S. reapplication ～ Approval, Launch | delay Received CRL, | ||
Preparing for reapplication | ||||
DWR-2206 | Start of Phase lI study in Japan | achieved Dosing completed for subject | ||
DW-1002 | Application, approval and Launch in China, Application in Japan | delay | ||
New projects Research progress (including⇒ new collaborations)
Multiple joint research projects are underway
Copyright D. Western Therapeutics Institute, Inc. All Rights Reserved. | 10 |