Translation - Original Text in Japanese

JCR Pharmaceuticals Co., Ltd. (4552)

Financial Summary

Consolidated Financial Results for the Year ended March 31, 2023 (FY2022)

(Japanese standard)

May 11, 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: 0797(32)1995

Scheduled date to hold the ordinary general meeting of shareholders: June 21, 2023

Scheduled date to commence dividend payments: June 22, 2023

Scheduled date to file the Securities Report: June 21, 2023

Explanatory material for business results: Available

IR Conference: To be held (for institutional investors and analysts)

(Fractions smaller than one million yen omitted)

1. Consolidated Financial Results for FY2022 (April 1, 2022 to March 31, 2023)

(1) Consolidated Operating Results (Cumulative)

(Percentage shows year-on-year changes.)

Net sales

Operating income

Ordinary income

Profit attributable

to owners of parent

Year ended

million yen

%

million yen

%

million yen

%

million yen

%

March 31, 2023

34,343

(32.8)

4,975

(75.0)

5,418

(73.6)

3,772

(74.0)

March 31, 2022

51,082

69.8

19,933

141.1

20,512

141.6

14,507

110.5

(Reference)

Comprehensive income: Year ended March 31, 2023: 3,881 million yen ([73.3]%)

Year ended March 31, 2022: 14,514 million yen (112.2%)

Earnings per

Earnings per

Return on equity

Ordinary income

Operating income to

share (basic)

share (diluted)

to total assets

Net sales

Year ended

yen

yen

%

%

%

March 31, 2023

30.35

30.22

7.4

5.6

14.5

March 31, 2022

117.26

116.80

32.9

24.0

39.0

(Reference)

Gains/(losses) on equity method investments:

For the year ended March 31, 2023 (7) million yen For the year ended March 31, 2022 -- million yen

(2) Consolidated Financial Conditions

Total assets

Net assets

Equity ratio

Net asset per share

Year ended

million yen

million yen

%

yen

March 31, 2023

94,937

52,413

54.2

412.11

March 31, 2022

97,134

51,089

51.8

406.57

(Reference)

Shareholders' equity: As of March 31, 2023: 51,421 million yen

As of March 31, 2022: 50,316 million yen

(3) Consolidated Cash Flows

Cash flows from

Cash flows from

Cash flows from

Cash and cash equivalents

operating activities

investing activities

financing activities

at end of period

Year ended

million yen

million yen

million yen

million yen

March 31, 2023

(5,500)

(15,002)

1,948

13,278

March 31, 2022

9,289

(3,250)

(2,179)

30,733

2. Dividends

Dividends per share

Total

Dividend

Dividends on

annual

1st

2nd

3rd

pay-out ratio

net assets

Year-end

Total

dividends

quarter-end

quarter-end

quarter-end

(consolidated)

(consolidated)

(total)

yen

yen

yen

yen

yen

million yen

%

%

FY2021

-

10.00

-

12.00

22.00

2,730

18.8

6.2

FY2022

-

10.00

-

10.00

20.00

2,502

65.9

4.9

FY2023 (Forecast)

-

10.00

-

10.00

20.00

65.4

(Note) Breakdown of the year-end dividend for the fiscal year ended March 31, 2022 Ordinary dividend: 10.00 yen

Special dividend: 2.00 yen

Translation - Original Text in Japanese

JCR Pharmaceuticals Co., Ltd. (4552)

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 income

Ordinary income

attributable to owners

share

of 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

  1. Changes in significant subsidiaries during the period
    (Changes in specified subsidiaries resulting in the change in consolidation scope): 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. : Yes

2.

Changes in accounting principles other than 1.

: None

3.

Changes in accounting estimates

: None

4.

Restatements

: None

(Note) For details, please refer to "3. Quarterly consolidated financial statements and important notes, (5) Notes to Consolidated Financial Statements, (Changes in accounting policy)" on page 13 of the attached material.

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

As of March 31, 2023

129,686,308 shares

As of March 31, 2022

129,686,308 shares

As of March 31, 2023

4,910,773 shares

As of March 31, 2022

5,929,344 shares

As of March 31, 2023

124,307,714 shares

As of March 31, 2022

123,720,398 shares

(Reference) Summary of Individual Business Results

1. Individual Business Results for FY2022 (From April 1, 2022 to March 31, 2023)

(1) Individual Business Results

(% figures represent annual changes over the preceding year)

Net sales

Operating income

Ordinary income

Net income for the year

Year ended

million yen

%

million yen

%

million yen

%

million yen

%

March 31, 2023

34,343

(32.8)

5,095

(74.7)

5,284

(74.1)

3,687

(74.5)

March 31, 2022

51,081

69.8

20,137

133.0

20,425

137.7

14,446

104.0

Earnings per share

Earnings per share

(basic)

(diluted)

Year ended

Yen

Yen

March 31, 2023

29.67

29.54

March 31, 2022

116.77

116.31

(2) Individual Financial Conditions

Total assets

Net assets

Equity ratio

Net asset per share

Year ended

million yen

million yen

%

yen

March 31, 2023

94,551

52,006

54.2

410.86

March 31, 2022

97,033

50,939

51.9

407.02

(Reference) Shareholders' equity; As of March 31, 2023: 51,265 million yen As of March 31, 2022: 50,371 million yen

  • These annual financial results are not subject to audits by certified public accounts and audit firms.
  • Explanations and other special notes concerning the appropriate use of business performance forecasts

The forward-looking statements such as a result forecasts in this document are based on the information available to the Company at the time of the announcement and on certain assumptions considered reasonable, which are inherently speculative, and actual results may differ materially from the forecast depending on various factors. As for notes, etc. of the conditions as a prerequisite and the appropriated use for business performance forecasts, please refer to page 2 of the Attached Material, "Overview of Financial Results."

Translation - Original Text in Japanese

JCR Pharmaceuticals Co., Ltd. (4552)

  • Table of Contents for Attached Material

1. Overview of Financial Results, Etc

2

(1) Overview of Financial Results

2

(2) Overview of Financial Conditions

3

(3) Basic Policy on the Distribution of Profits/Dividends for FY2022 and FY2023

4

2. Basic Concept Regarding Selection of Accounting Standard

4

3.

Consolidated Financial Statements

5

(1) Consolidated Balance Sheets

5

(2) Consolidated Statements of Income and Consolidated Statements of Comprehensive Income

(Consolidated Statements of Income)

7

(Consolidated Statements of Comprehensive Income)

8

(3) Consolidated Statements of Changes in Net Assets

9

(4) Consolidated Statements of Cash Flows

11

(5) Notes to Consolidated Financial Statements

12

(Notes on premises as a going concern)

12

(Changes in accounting policy)

12

(Concerning consolidated statements of income)

12

(Segment information)

12

(Per share information)

13

(Important Subsequent Events)

13

4.

Other

14

R&D Pipeline

14

- 1 -

Translation - Original Text in Japanese

JCR Pharmaceuticals Co., Ltd. (4552)

1. Overview of Financial Results, Etc.

(1) Overview of Financial Results

  1. Financial results for the year
    Net sales amounted to 34,343 million yen (down 32.8% year on year),
    Sales volume for our recombinant human growth hormone product GROWJECT® increased, but sales were affected by the NHI price revision in April 2022. Total net sales of our main products remained level year on year. Although sales of treatment for renal anemia decreased significantly as a result of similar NHI price revisions, there was a substantial contribution from IZCARGO® for I.V. infusion 10mg, which was placed on the NHI reimbursement price list in May 2021.
    In areas other than our main products, total net sales decreased year on year, due to factors such as a decrease in income from contractual payments and the completion of the contract to manufacture AstraZeneca K.K.'s COVID-19 vaccine solution in Japan as planned.
    On the profit front, due to factors including a decrease in gross profit (down 37.3% year on year) in conjunction with decreased net sales, operating income decreased by 75.0% to 4,975 million yen, ordinary income decreased 73.6% to 5,418 million yen, and profit attributable to owners of parent decreased 74.0% to 3,772 million yen.
    As a result of proactive R&D activities and development activities in line with progress on clinical trials, R&D expenses totaled 8,802 million yen (up 1,626 million yen, or 22.7%, year on year).

Previous consolidated results

Current consolidated results

Rate of change

(From April 1, 2021 to March 31, 2022)

(From April 1, 2022 to March 31, 2023)

Amount (million yen)

Amount (million yen)

%

Net sales

51,082

34,343

(32.8)

Operating income

19,933

4,975

(75.0)

Ordinary income

20,512

5,418

(73.6)

Profit attributable to owners of parent

14,507

3,772

(74.0)

[2] Main components of sales

Previous consolidated results

Current consolidated results

Rate of change

Name of business segment

(From April 1, 2021 to March 31, 2022)

(From April 1, 2022 to March 31, 2023)

Amount (million yen)

Amount (million yen)

%

Human growth hormone product

12,945

12,261

(5.3)

GROWJECT®

Treatment for mucopolysaccharidosis type II

3,003

4,428

47.4

IZCARGO® for I.V. Infusion

Treatment for renal anemia

5,875

4,696

(20.1)

Epoetin Alfa BS Inj. [JCR]

2,876

2,710

(5.8)

Darbepoetin Alfa BS Inj. [JCR]

2,998

1,986

(33.7)

Regenerative medicine products

3,497

3,404

(2.7)

TEMCELL® HS Inj.

Treatment for Fabry disease

Agalsidase Beta BS I.V. Infusion

711

964

35.6

[JCR]

Medical devices

102

103

1.3

Income from contractual payment

10,571

6,546

(38.1)

AZD1222 stock solution

14,375

1,931

(86.6)

Note: Income from contractual payments is derived from the conclusion of agreements concerning commercialization and sales alliances.

[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) technology, J- Brain Cargo®, as treatments for over 17 types of lysosomal storage disorders.
  • For pabinafusp alfa (development code: JR-141), our BBB penetrating technology 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 candidate 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 treatment enzyme formulation for mucopolysaccharidosis IIIA (Sanfilippo syndrome type A) (development code: JR-441), we are currently making efforts to begin a global clinical trial at an early stage in FY2023.
    • 2 -

Translation - Original Text in Japanese

JCR Pharmaceuticals Co., Ltd. (4552)

  • As for the BBB-penetrating treatment enzyme formulation for mucopolysaccharidosis 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 lysosomal storage disorders 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 excluding 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 penetration technology J-Brain Cargo® to various modalities, we are focused on creating new platform technologies following J-Brain Cargo® technology.
  • In March 2023, we achieved a preclinical proof-of-concept milestone based on a research and development collaboration agreement with Takeda Pharmaceutical Company Limited concerning gene therapies that apply our J-Brain Cargo® to lysosomal storage disorders.
  • In March 2023, we signed Research Collaboration, Option and License Agreement with Alexion, AstraZeneca Rare Disease to develop an undisclosed therapeutic molecule that applies our J-Brain Cargo® technology for the treatment of a neurodegenerative disease.

[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.
  • In April 2022, we reached an agreement with Teijin Ltd. to terminate our contract to co-develop an allogeneic regenerative medical product using dental pulp stem cells (DPCs) for the indication of acute cerebral infarction (development code: JTR-161/JR-161).

[Human growth hormone product]

  • In July 2022, we filed for marketing approval of an additional indication for 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), and 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.

[4] Forecast for the next term

Forecast for the next consolidated financial results are as follows.

Current year actuals

Forecast for the next year

Increase or decrease

Increase-decrease rate

(Year ended March 2023)

(Year ended March 2024)

Net sales (millions of yen)

34,343

36,900

2,556

7.4 %

Operating income

4,975

5,600

624

12.5 %

(millions of yen)

Ordinary income

5,418

5,200

(218)

(4.0) %

(millions of yen)

Profit attributable to owners of

3,772

3,800

27

0.7%

parent (millions of yen)

(Net sales)

We anticipate an increase in sales through steady growth of sales volume of IZCARGO® for the treatment of Hunter syndrome and Agalsidase Beta for the treatment of Fabry disease, and sales of main products are projected to be on par with FY2022. In addition, we are continuing to work actively in licensing business.

(Profit)

Over the next several years, we project active investment in R&D activities, which we regard as a critical element in further advancing our business. Despite an increase in R&D expenses, operating income is forecast to increase by 12.5% compared to FY2022 to 5.6 billion yen. We accordingly anticipate ordinary income of 5.2 billion yen (down 4.0% year on year) and profit attributable to owners of parent of 3.8 billion yen (up 0.7%).

(2) Overview of Financial Conditions

  1. Status of assets, liabilities and net assets
    As of March 31, 2023, total assets amounted to 94,937 million yen (a decrease of 2,196 million yen from March 31, 2022), total liabilities were 42,523 million yen (a decrease of 3,521 million yen from March 31, 2022), and net assets were 52,413 million yen (an increase of 1,324 million yen from March 31, 2022).
    Current assets decreased by 14,385 million yen from March 31, 2022 to 47,802 million yen due to factors including decreases in cash and deposits, accounts receivable - trade, and contract assets. Non-current assets increased by 12,188 million yen from March 31, 2022 to 47,135 million yen, mainly due to an increase in property, plant and equipment.
    Current liabilities decreased by 6,292 million yen from March 31, 2022 to 35,762 million yen, mainly due to a decrease in income
    • 3 -

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JCR Pharmaceuticals Co. Ltd. published this content on 30 May 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 08 June 2023 07:23:08 UTC.