JCR Pharmaceuticals : FY2023-Q1 Financial Report (Apr. 1-Jun. 30, 2023)（413KB）

Translation - Original Text in Japanese

JCR Pharmaceuticals Co., Ltd. (4552)

Financial Summary

Consolidated Financial Results for the Three Months ended June 30, 2023 (FY2023)

(Japanese standard)

July 26, 2023

Listed company name: JCR Pharmaceuticals Co., Ltd.
Listed stock exchange: Tokyo Stock Exchange
Code number:	4552	URL: https://www.jcrpharm.co.jp
Representative:		(Title) Representative Director, Chairman and President
		(Name) Shin Ashida
Person in charge of inquiries:	(Title) Senior Corporate Officer, Executive Director, Corporate Strategy Division
		(Name) Yoh Ito	TEL: [phone]

Scheduled date to file Quarterly Securities Report: August 10, 2023

Scheduled date to commence dividend payments: -

Preparation of supplemental information for this financial summary: Available

IR Conference: None

(Fractions smaller than one million yen omitted)

1. Consolidated Financial Results for 1Q FY2023 (April 1, 2023 to June 30, 2023)

(1) Consolidated Operating Results (Cumulative)				(Percentage shows year-on-year changes.)
		Net sales				Operating profit	Ordinary profit	Profit attributable
													to owners of parent
Three Months Ended	million yen		%		million yen	%	million yen		%	million yen	%
June30, 2023	10,808		12.5		2,066	34.5	2,260		8.5	1,610	17.7
June30, 2022	9,606		(2.1)		1,536	(48.5)	2,083		(30.5)	1,368	(10.7)
(Reference)	Comprehensive income: Three months ended June 30, 2023: 1,789 million yen (30.5%)
		Three months ended June 30, 2022: 1,370 million yen (-7.2%)
		Earnings per		Earnings per
		share (basic)		share (diluted)
Three Months Ended	yen				yen
June30, 2023	12.91				12.85
June30, 2022	11.06				11.02
(2) Consolidated Financial Conditions
		Total assets				Net assets		Equity ratio
AS of		million yen		million yen			%
June30, 2023	95,775				52,959			54.3
March 31, 2023	94,937				52,413			54.2

(Reference) Shareholders' equity: As of June 30, 2023: 51,969 million yen As of March 31, 2023: 51,421 million yen

2. Dividends

		Dividends per share
	1st quarter-end	2nd quarter-end	3rd quarter-end	Year-end	Annual
	yen	yen	yen	yen	yen
FY2022	-	10.00	-	10.00	20.00
FY2023	-
FY2023 (Forecast)		10.00	-	10.00	20.00

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

3. Consolidated Forecasts for the Fiscal Year Ending March 31, 2024 (April 1, 2023 to March 31, 2024)

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

								Profit		Earnings per
	Net sales		Operating profit	Ordinary profit	attributable to owners
		share
								of the parent
	million yen		%	million yen	%	million yen	%	million yen		%	yen
Year ending	36,900		7.4	5,600	12.5	5,200	(4.0)	3,800		0.7	30.56
March 31, 2024
(Notes) No revisions were made to the most recently announced financial results forecast.

Translation - Original Text in Japanese

JCR Pharmaceuticals Co., Ltd. (4552)

*Note

1. Changes in significant subsidiaries during the period

(Changes in specified subsidiaries resulting in the change in consolidation scope): None

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

1. Number of shares outstanding (common stocks)
2. 1. Number of shares outstanding at the end of the period (including treasury stock)
   2. Number of treasury stock at the end of the period
   3. Average number of shares outstanding during the period (quarterly cumulative amount)

As of June 30, 2023	129,686,308 shares	As of March 31, 2023	129,686,308 shares
As of June 30, 2023	4,897,814 shares	As of March 31, 2023	4,910,773 shares
As of June 30, 2023	124,782,090 shares	As of June 30, 2022	123,762,831 shares

• The quarterly financial statements are outside of the scope of quarterly review by a certified public accountant or an audit firm.
• 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. Qualitative information for quarterly financial statements, (3) Explanation on projections such as forecasts of consolidated financial results" on page 4 of the attached material.

Translation - Original Text in Japanese

	JCR Pharmaceuticals Co., Ltd. (4552)
 Table of Contents for Attached Material
1. Qualitative information for quarterly financial statements	2
(1)	Explanation on financial results	2
(2)	Overview of financial conditions	4
(3)	Explanation on projections such as forecasts of consolidated financial results	4
2. Quarterly consolidated financial statements and important notes	5
(1)	Quarterly consolidated balance sheets	5
(2)	Quarterly consolidated statements of income and quarterly consolidated statements of comprehensive income...	7
	(Quarterly consolidated statements of income)	7
	(Quarterly consolidated statements of comprehensive income)	8
(3) Notes to quarterly consolidated financial statements	9
	(Notes on premises as a going concern)	9
	(Notes on any significant changes in the amount of shareholders' equity)	9

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Translation - Original Text in Japanese

JCR Pharmaceuticals Co., Ltd. (4552)

1. Qualitative information for quarterly financial statements

(1) Explanation on financial results

1. Financial results for 1Q FY2023
   Net sales amounted to 10,808 million yen (up 12.5% year on year).
   Sales volumes for our recombinant human growth hormone product GROWJECT® and treatment for renal anemia increased significantly in spite of an NHI price revision in April 2023, while sales were also brisk for IZCARGO® for I.V. infusion 10mg. Strong sales of our main products ensured total net sales increased year on year although there was a decrease in income due to the completion of the contract to manufacture AstraZeneca K.K.'s COVID-19 vaccine solution in Japan as planned.
   All profit lines grew, as operating profit increased by 34.5% year on year to 2,066 million yen, ordinary profit increased by 8.5% to 2,260 million yen, and profit attributable to owners of parent increased by 17.7% to 1,610 million yen.
   As a result of proactive R&D activities, R&D expenses totaled 2,294 million yen (up 103 million yen, or 4.7%, year on year).

	Previous quarterly consolidated results		Current quarterly consolidated results
	(cumulative)		(cumulative)	Rate of change
	(April 1, 2022 to June 30, 2022)		(April 1, 2023 to June 30, 2023)
	Amount (millions of yen)		Amount (millions of yen)	%
Net sales	9,606	10,808	12.5
Operating profit	1,536	2,066	34.5
Ordinary profit	2,083	2,260	8.5
Profit attributable to owners of the parent	1,368	1,610	17.7
[2] Main components of sales
	Previous quarterly consolidated results		Current quarterly consolidated results
	(cumulative)		(cumulative)	Rate of change
	(April 1, 2022 to June 30, 2022)		(April 1, 2023 to June 30, 2023)
	Amount (millions of yen)		Amount (millions of yen)	%
Human growth hormone product	3,134		4,222	34.7
GROWJECT®
Treatment for mucopolysaccharidosis type II	1,070		1,239	15.8
IZCARGO® for I.V. Infusion
Treatment for renal anemia	875		1,615	84.5
Epoetin Alfa BS Inj. [JCR]	660		602	(8.8)
Darbepoetin Alfa BS Inj. [JCR]	214		1,012	371.0
Regenerative medicine products	1,041		1,063	2.1
TEMCELL® HS Inj.
Treatment for Fabry disease
Agalsidase Beta BS I.V. Infusion	519		471	(9.3)
[JCR]
Others	－		547	－
Medical devices	21		37	69.5
Income from contractual payment	1,010		1,612	59.6
AZD1222 stock solution	1,931		－	－

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Translation - Original Text in Japanese

JCR Pharmaceuticals Co., Ltd. (4552)

[3] The Status of R&D

[Treatments for lysosomal storage disorders]

• Currently, we are focused on research and development of new drugs that employ our unique blood-brain barrier (BBB) penetrating technology, J-Brain Cargo®, as treatments for over 17 types of lysosomal storage disorders (LSD).
• For pabinafusp alfa (development code: JR-141), our BBB penetrating product for the treatment of patients with Hunter syndrome, in the U.S. we received Rare Pediatric Disease (*) designation by the U.S. Food and Drug Administration (FDA) in December 2022. In February 2022, the first patient was dosed in a global Phase III clinical trial, and we are now in the process of conducting patient enrolment. Furthermore, although we had filed for marketing approval of JR-141 in Brazil with the Brazilian Health Regulatory Agency (ANVISA) in December 2020, our application was denied in August 2022. We plan to file another application using the results of the global Phase III clinical trial currently being conducted.
• For lepunafusp alfa (development code: JR-171), our BBB-penetrating product for the treatment of patients with mucopolysaccharidosis type I (MPS I), in the ongoing Phase I/II clinical trial in Japan, Brazil, and the U.S., we completed scheduled patient enrolment in March 2022, and are conducting a final analysis. Preparations are underway to quickly begin the global Phase III clinical trial.
• Regarding the BBB-penetrating product for MPS IIIA (Sanfilippo syndrome type A) (development code: JR-441), the Paul-Ehrlich- Institut (PEI), the regulatory authority for the Federal Republic of Germany, accepted a clinical trial application (CTA) for a Phase I/II clinical trial. We are currently finalizing the clinical trial protocol and aim to start recruitment in the first half of FY2023.
• As for the BBB-penetrating product for MPS IIIB (Sanfilippo syndrome type B) (development code: JR-446), we are currently making efforts to begin a global clinical trial at an early stage during FY2024.
• We have also been successively conducting R&D into other treatments for LSDs that employ J-Brain Cargo®, including a treatment for Pompe disease (development code: JR-162), a treatment for Sly syndrome (development code: JR-443), and a treatment for GM2 gangliosidosis (development code: JR-479). We will also develop each of these treatments globally. Furthermore, with regard to our fucosidosis therapeutic (development code: JR-471), based on a licensing agreement concluded in October 2022, MEDIPAL HOLDINGS CORPORATION was granted the right to obtain an exclusive license with sublicensing rights for global commercialization which includes research, development, manufacturing and marketing outside Japan. We will participate from the position of licenser as the company that created this therapeutic, and help to commercialize it at an early stage.

[Creating platform technologies]

• In addition to research that will widen the potential for application of JCR's unique BBB-penetrating technology J-Brain Cargo® to various modalities, we are focused on creating new platform technologies following J-Brain Cargo® technology.
• In May 2023 we entered into an exclusive global development and commercialization agreement with Angelini Pharma S.p.a. for the development of novel biologic therapies applying J-Brain Cargo® technology for the treatment of epilepsy.

[Regenerative medicine products]

• We have completed a Phase I/II clinical trial of TEMCELL® HS Inj. for the additional indication of neonatal hypoxic ischemic encephalopathy (HIE) (development code: JR-031HIE), and are currently conducting analysis.

[Human growth hormone product]

• In June 2023, we received partially amended approval for an expanded indication of GROWJECT® in patients with short stature homeobox containing gene (SHOX) deficiency (development code: JR-401X).
• We also initiated a Phase II clinical trial of a recombinant long-acting growth hormone (development code: JR-142), have completed the scheduled statistical analysis and are preparing to start a Phase III clinical trial.

* Rare Pediatric Disease Designation

This designation is intended to facilitate the development of new drugs and biologics for the prevention and treatment of rare pediatric diseases. JCR may become eligible to receive a voucher for a priority review of a subsequent marketing application in the U.S.

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