JCR Pharmaceuticals : FY2025-Q1 Financial Report (Apr. 1-Jun. 30, 2025)（340KB）

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.

July 30, 2025

Listed company name: JCR Pharmaceuticals Co., Ltd. Listed stock exchange: Tokyo Stock Exchange

Code number: 4552 URL: https://jcrpharm.com/

Representative: (Title) Representative Director, Chairman and President (Name) Shin Ashida

Person in charge of inquiries: (Title) Senior Executive Officer, Executive Director, Corporate Strategy Division (Name) Yoh Ito TEL: 0797(32)1995

Scheduled date to commence dividend payments: -

Preparation of supplemental information for this financial summary: Available IR Conference: To be held (for institutional investors and analysts)

(Fractions smaller than one million yen omitted)

1. Consolidated Financial Results for 1Q FY2025 (April 1, 2025 to June 30, 2025)

   1. Consolidated Operating Results (Cumulative) (Percentage shows year-on-year changes.)

      	Net sales		Operating profit (loss)		Ordinary profit (loss)		Profit attributable to owners of parent
      Three months ended	million yen	%	million yen	%	million yen	%	million yen	%
      June 30, 2025	8,569	5.2	(606)	-	(749)	-	(546)	-
      June 30, 2024	8,145	(24.6)	(296)	-	(257)	-	201	(87.5)

      (Reference) Comprehensive income: Three months ended June 30, 2025: 388 million yen ([11.8]%)

      Three months ended June 30, 2024: 441 million yen ([75.4]%)

      	Earnings per share (basic)	Earnings per share (diluted)
      Three months ended	yen	yen
      June 30, 2025	(4.48)	-
      June 30, 2024	1.61	1.61

      (Note) "Earnings per share (diluted)" for the first quarter of the fiscal year ending March 2026 is not stated because there was a net loss per share, even though there were residual shares.

   2. Consolidated Financial Conditions

   	Total assets	Net assets	Equity ratio
   As of	million yen	million yen	%
   June 30, 2025	107,337	46,614	43.0
   March 31, 2025	104,855	47,435	44.8

   (Reference) Shareholders' equity: As of June 30, 2025: 46,188 million yen

   As of March 31, 2025: 46,967 million yen

2. Dividends

   		Dividends		per share
   	1st quarter-end	2nd quarter-end	3rd quarter-end		Year-end	Annual
   	yen	yen		yen	yen	yen
   FY2024	-	10.00		-	10.00	20.00
   FY2025	-
   FY2025 (Forecast)		10.00	-		10.00	20.00

   (Note) No revisions were made to the most recently announced dividend forecast.

3. Consolidated Forecasts for the Fiscal Year Ending March 31, 2026 (April 1, 2025 to March 31, 2026)

(Percentage figures for the fiscal year represent the changes from the previous year.)

(Note) No revisions were made to the most recently announced financial results forecast.

*Notes

1. Changes in significant subsidiaries during the period: None

2. Application of specific accounting practices for preparing quarterly consolidated financial statements: None

3. Changes in accounting policy, changes in accounting estimates and restatements

   1. Changes in accounting policy due to the revision of accounting standards, etc. : None

   2. Changes in accounting principles other than 1. : None

   3. Changes in accounting estimates : None

   4. Restatements : None

4. Number of shares outstanding (common stocks)

• Review of accompanying quarterly consolidated financial statements by certified public accountants or auditing firms: None

• Explanation on the appropriate use of forecasts of financial results and other comments (Note on forward-looking statements, etc.)

Forward-looking statements, such as forecasts of financial results, contained in this document are based on information currently available to the Company and certain assumption that are judged as rational. The Company does not assure the achievement of these forecasts. In addition, actual financial results may differ significantly from forecasts due to various reasons. For assumptions underlying forecasts of financial results and notes regarding the appropriate use of forecasts of financial results, please refer to "1. Overview of Financial Results, Etc., (3) Explanation on Projections such as Forecasts of Consolidated Financial Results" on page 3 of the attached material.

• Table of Contents for Attached Material

  1. Overview of Financial Results, Etc. 2

     1. Overview of Quarterly Financial Results 2

     2. Overview of Quarterly Financial Conditions 3

     3. Explanation on Projections such as Forecasts of Consolidated Financial Results 3

  2. Quarterly Consolidated Financial Statements and Important Notes 4

     1. Quarterly Consolidated Balance Sheets 4

     2. Quarterly Consolidated Statements of Income and Consolidated Statements of Comprehensive Income 6

        (Quarterly Consolidated Statements of Income) 6

        (Quarterly Consolidated Statements of Comprehensive Income) 7

     3. Notes to Quarterly Consolidated Financial Statements 8

(Notes on Segment Information) 8

(Notes on any significant changes in the amount of shareholders' equity) 8

(Notes on premises as a going concern) 8

(Notes on consolidated statement of cash flows) 8

1. ‌Overview of Financial Results, Etc.

   1. ‌Overview of Quarterly Financial Results

      1. Financial Results for 1Q FY2025

         Net sales amounted to 8,569 million yen (up 5.2% year on year).

         Sales of IZCARGO®10mg for intravenous infusion, a treatment for mucopolysaccharidosis type II, remained strong. Sales of GROWJECT®, a recombinant natural human growth hormone preparation, decreased due to a drug price revision in April 2025. However, total net sales increased year on year as overall product sales remained strong and income from contractual payment increased.

         R&D expenses totaled 3,348 million yen (up 172 million yen, or 5.4%, year on year) reflecting proactive R&D activities.

         As a result, the Company recorded an operating loss of 606 million yen (operating loss of 296 million yen in the same period of the previous fiscal year), an ordinary loss of 749 million yen (ordinary loss of 257 million yen in the same period of the previous fiscal year), and a loss attributable to owners of the parent of 546 million yen (net income of 201 million yen in the same period of the previous fiscal year).

         	Previous quarterly consolidated results (cumulative) (April 1, 2024 to June 30, 2024)	Current quarterly consolidated results (cumulative) (April 1, 2025 to June 30, 2025)	Rate of change
         	Amount (million yen)	Amount (million yen)	%
         Net sales	8,145	8,569	5.2
         Operating profit (loss)	(296)	(606)	-
         Ordinary profit (loss)	(257)	(749)	-
         Profit (loss) attributable to owners of parent	201	(546)	-

      2. Main components of sales

         	Previous quarterly consolidated results (cumulative) (April 1, 2024 to June 30, 2024)	Current quarterly consolidated results (cumulative) (April 1, 2025 to June 30, 2025)	Rate of change
         	Amount (million yen)	Amount (million yen)	%
         Human growth hormone product GROWJECT®	4,649	4,495	(3.3)
         Treatment for mucopolysaccharidosis type II IZCARGO®for I.V. Infusion	1,372	1,562	13.9
         Treatment for renal anemia Epoetin Alfa BS Inj. [JCR] Darbepoetin Alfa BS Inj. [JCR]	907 515 392	897 122 775	(1.2) (76.3) 97.6
         Regenerative medicine products TEMCELL®HS Inj.	730	845	15.8
         Treatment for Fabry disease Agalsidase Beta BS I.V. Infusion [JCR]	277	426	53.8
         Total	7,936	8,226	3.6
         Income from contractual payment	15	106	582.2

      3. The Status of Research and Development (R&D) [Lysosomal Storage Disorder (LSD) Treatments]

         • We are currently focusing on the research and development of over 17 LSD treatments, utilizing our proprietary blood-brain barrier (BBB) penetration technology, J-Brain Cargo®.

         • For pabinafusp alfa (JR-141), a BBB-penetrating enzyme replacement therapy for Hunter syndrome, we are progressing with global Phase III clinical trials. These trials are progressing smoothly, and the target number of cases has been achieved. In addition, we held a meeting with the U.S. Food and Drug Administration (FDA) in June 2025 to discuss our strategy for new drug application (NDA).

         • For lepunafusp alfa (JR-171), a BBB-penetrating enzyme replacement therapy for mucopolysaccharidosis type I, we have completed a 13-week Phase I/II clinical trial in Japan, Brazil, and the U.S., and are continuing with an extension study. We intend to develop this product through licensing out and are in ongoing negotiations with potential partners.

         • For JR-441, a BBB-penetrating enzyme replacement therapy for mucopolysaccharidosis type IIIA, a Phase I/II clinical trial is underway in Germany, and the planned enrollment of 12 subjects was completed in the first half of 2024. We have also enrolled the target number of patients for Phase I trials in Japan, and the trials are progressing smoothly. Additionally, the treatment has been granted orphan drug designation by the European Commission (EC) in January 2022, by the U.S. Food and Drug Administration (FDA) in December 2023, and the Japan's Ministry of Health, Labour and Welfare in December 2024.

         • For JR-446, a BBB-penetrating enzyme replacement therapy for mucopolysaccharidosis type IIIB, we entered into a licensing agreement for overseas commercialization and a co-development and commercialization agreement in Japan with MEDIPAL HOLDINGS CORPORATION in September 2023. In December 2024, administration of the investigational drug in a Phase I/II clinical trial began in Japan. The treatment was granted orphan drug designation by the FDA in April 2025 and by EC in June 2025.

         • For JR-471, a BBB-penetrating enzyme replacement therapy for fucosidosis using J-Brain Cargo®, we have granted MEDIPAL HOLDINGS CORPORATION an exclusive license, including sublicensing rights, for the research, development, manufacturing, and commercialization of the product outside Japan, under a licensing agreement signed in October 2022. We are currently conducting necessary studies in preparation for the initiation of clinical trials.

           [Human Growth Hormone Products]

         • An extension study of redalsomatropin alfa (JR-142), a long-acting recombinant human growth hormone, began administration of the investigational drug in a Phase III clinical trial in Japan in December 2024. Additionally, it is underway as part of a Phase II clinical trial.

           [Creation of Platform Technologies] J-Brain Cargo®

         • In addition to expanding the applicability of JCR's proprietary J-Brain Cargo®technology to various modalities, we are focusing on licensing-out of this technology. In July 2025, we entered into an option agreement with Acumen Pharmaceuticals, Inc. for the

           licensing of the J-Brain Cargo®technology for the development of a blood-brain barrier-penetrating Alzheimer's disease treatment.

           JUST-AAV

         • We are focusing on creating new platform technologies beyond J-Brain Cargo®. One of the outcomes of these efforts is the creation of a new gene therapy technology called 'JUST-AAV' using adeno-associated virus (AAV) vectors. This technology not only enables efficient delivery of vectors to the brain but also reduces vector accumulation in the liver, which is expected to mitigate side effects. It is currently under development as a new platform technology. In December 2023, we began joint research with Modalis Therapeutics Corporation to develop new gene therapies using this technology. In January 2025, due to the success of the partnership thus far, we concluded to proceed to the next phase of their research by entering into a new joint research agreement. In addition, in July 2025, we entered into a license agreement with Alexion, AstraZeneca Rare Diseases to license the JUST-AAV capsids for the development of new genomic medicines.

   2. ‌Overview of Quarterly Financial Conditions

      As of June 30, 2025, total assets amounted to 107,337 million yen (an increase of 2,481million yen from March 31, 2025), total liabilities were 60,722 million yen (an increase of 3,302 million yen from March 31, 2025), and net assets were 46,614 million yen (a decrease of 821 million yen from March 31, 2025).

      Current assets increased by 1,596 million yen from March 31, 2025 to 52,653 million yen due to factors including a decrease in accounts receivable - other and increases in accounts receivable - trade, contract assets, and inventories. Non-current assets increased by 884 million yen from March 31, 2025 to 54,683 million yen due to factors including a decrease in deferred tax assets and an increase in investment securities.

      Current liabilities increased by 3,404 million yen from March 31, 2025 to 47,393 million yen mainly due to increases in short-term borrowings and provision for bonuses. Non-current liabilities remained about level with March 31, 2025 at 13,329 million yen.

      Net assets decreased by 821 million yen from March 31, 2025 to 46,614 million yen mainly due to the recording of loss attributable to owners of parent and the payment of dividends, despite an increase in valuation difference on available-for-sale securities.

      As a result, the equity ratio as of June 30, 2025 was 43.0%, down 1.8 percentage points from March 31, 2025.

      In order to achieve sustainable global growth, we need to secure a flexible and stable source of funds. We concluded commitment line agreements with our financial institutions for a total of 49,500 million yen for the purpose of securing operating funds as a backup plan.

      Of this amount, 26,500 million yen has been concluded to finance the construction of a new plant for drug product filling and finishing. The construction of this new plant has been adopted by the Ministry of Economy, Trade and Industry (METI) under the project of Establishing Biopharmaceutical Manufacturing Sites to Strengthen Vaccine Production, and the subsidy from this project will be used to construct the new plant. The purpose of the commitment line agreement is to provide the necessary funds until we receive the subsidy.

   3. ‌Explanation on Projections such as Forecasts of Consolidated Financial Results

   Looking at consolidated financial results for the three months ended June 30, 2025, net sales increased, but profits decreased year on year. As these results were in line with our initial forecasts, there have been no changes to the forecasts for the fiscal year ending March 31, 2026 announced on May 13, 2025.

2. ‌Quarterly Consolidated Financial Statements and Important Notes

1. ‌Quarterly Consolidated Balance Sheets

   (Millions of yen)

   As of March 31, 2025 As of June 30, 2025

   Assets

   Current assets

   Cash and deposits	13,196	13,180
   Accounts receivable - trade, and contract assets	12,236	13,326
   Merchandise and finished goods	2,571	2,374
   Work in process	6,388	7,105
   Raw materials and supplies	12,799	13,235
   Other	3,866	3,430
   Total current assets	51,056	52,653

   Non-current assets

   Property, plant and equipment

Liabilities

(Millions of yen)

1. ‌ Quarterly Consolidated Statements of Income and Consolidated Statements of Comprehensive Income (Quarterly Consolidated Statements of Income)‌

   (Millions of yen)

   Three months ended June 30, 2024

   Three months ended June 30, 2025

   Net sales	8,145	8,569
   Cost of sales	2,073	2,357
   Gross profit	6,072	6,212
   Selling, general and administrative expenses	6,368	6,818
   Operating loss	(296)	(606)
   Non-operating income
   Interest income	27	9
   Dividend income	17	20
   Foreign exchange gains	435	-
   Compensation income	-	33
   Other	24	10
   Total non-operating income	505	74
   Non-operating expenses
   Share of loss of entities accounted for using equity method	200	45
   Interest expenses	26	79
   Commission expenses	17	16
   Depreciation	214	38
   Foreign exchange losses	-	27
   Other	6	10
   Total non-operating expenses	466	218
   Ordinary loss	(257)	(749)
   Extraordinary income
   Gain on cancellation of contract	627	-
   Total extraordinary income	627	-
   Extraordinary losses
   Loss on disposal of non-current assets	0	1
   Total extraordinary losses	0	1
   Profit (loss) before income taxes	369	(751)
   Income taxes - current	230	2
   Income taxes - deferred	(65)	(182)
   Total income taxes	164	(180)
   Profit (loss)	204	(570)
   Profit (loss) attributable to non-controlling interests	3	(24)
   Profit (loss) attributable to owners of parent	201	(546)

   ‌(Quarterly Consolidated Statements of Comprehensive Income)

   (Millions of yen)

   Three months ended June 30, 2024

   Three months ended June 30, 2025

   Profit (loss)	204	(570)
   Other comprehensive income
   Valuation difference on available-for-sale securities	(9)	1,035
   Deferred gains or losses on hedges	0	(0)
   Foreign currency translation adjustment	98	(72)
   Remeasurements of defined benefit plans, net of tax	(6)	(3)
   Share of other comprehensive income of entities accounted for 151 －
   using equity method
   Total other comprehensive income	236	959
   Comprehensive income	441	388
   Comprehensive income attributable to
   Comprehensive income attributable to owners of parent	418	431
   Comprehensive income attributable to non-controlling interests	22	(42)

2. ‌Notes to Quarterly Consolidated Financial Statements (Notes on segment information)‌

Segment information is not disclosed since the Group has only one segment, Pharmaceuticals.

‌(Notes on any significant changes in the amount of shareholders' equity)

Not applicable.

‌(Notes on going concern assumption) Not applicable.

‌(Notes on consolidated statement of cash flows)

The Company has not prepared a consolidated statement of cash flow for 1Q FY2025. Depreciation and amortization (including amortization of intangible assets) for 1Q FY2025 is as follows:

1Q FY2024

(April 1, 2024 to June 30, 2024)

1Q FY2025

(April 1, 2025 to June 30, 2025)

Depreciation and amortization 826 million yen 738 million yen