The following information was originally prepared and published by the Company in Japanese as it contains timely disclosure materials to be submitted to the Tokyo Stock Exchange. This English summary translation is for reference purposes only. To the extent there is any discrepancy between this English translation and the original Japanese version, please refer to the Japanese version. The following information was prepared in accordance with International Financial Reporting Standards ("IFRS").

Consolidated Financial Results for Q2 FY2019 (IFRS)

August 14, 2019

Company Name:

GNI Group Ltd.

Tokyo Stock Exchange

Stock Code:

2160

URL http://www.gnipharma.com

Representative:

Ying Luo, Director, Representative Executive Officer, President and CEO

Inquiries:

Thomas Eastling, Director, Representative Executive Officer, CFO

TEL: +81-3-6214-3600

Scheduled filing date of the securities report:

August 14, 2019

Scheduled dividend payment commencement date:

Supplementary materials prepared for financial results:

No

Holding of a financial results briefing meeting:

Yes (For analysts)

(Amounts of less than one million yen are rounded down)

1. Consolidated Financial Results for Q2 FY2019 (January 1, 2019 to June 30, 2019)

  1. Q2 FY2019 Consolidated Operating Results

(Percentages are shown as year-on-year changes)

Quarterly profit

Profit (loss)

Total comprehensive

Revenue

Operating profit

Profit before tax

attributable to

income (loss) for the

(loss)

owners of the parent

quarter

Million yen

%

Million yen

%

Million yen

%

Million yen

%

Million yen

%

Million yen

%

Q2 FY2019

3,419

58.4

681

184.5

603

837.8

501

178

141

Q2 FY2018

2,158

203.2

239

64

(6)

(176)

(88)

Basic earnings (loss) per

Diluted earnings

share

per share

Yen

Yen

Q2 FY2019

12.88

12.78

Q2 FY2018

(13.06)

Note: GNI Group consolidated its shares (consolidating 10 shares into 1 share) on July 1, 2018. Basic earnings (loss) per share and Diluted earnings per share for Q2 FY2018 have been calculated assuming consolidation as of January 1, 2018.

(2) Consolidated Financial Position

Total equity attributable to

Ratio of total equity

Total equity attributable to

Total assets

Total equity

attributable to owners of the

owners of the parent

owners of the parent per share

parent to total assets

Million yen

Million yen

Million yen

%

Yen

As of June 30, 2019

19,063

11,983

10,071

52.8

724.50

As of December 31, 2018

17,100

10,007

9,015

52.7

650.45

Note: GNI Group consolidated its shares (consolidating 10 shares into 1 share) on July 1, 2018. Total equity attributable to owners of the parent per share has been calculated assuming consolidation as of January 1, 2018.

2Dividends

Dividends per share

Q1

Q2

Q3

Year-end

Total

Yen

Yen

Yen

Yen

Yen

FY2018

0.00

0.00

FY2019

FY2019 (Forecast)

0.00

0.00

Note: Revision to the most recently announced forecasts of dividends per share: No

3Consolidated Earnings Forecasts for FY2019 (January 1, 2019 to December 31, 2019)

(Percentages are shown as year-on-year changes)

Revenue

Operating profit

Profit before tax

Profit for the year

Profit attributable to owners

Basic earnings per share

of the parent

Million yen

Million yen

Million yen

Million yen

Million yen

Yen

FY2019

7,119

41.8

757

33.2

742

103.6

453

135.9

100

7.41

Note: Revision to the most recently announced forecasts of financial results: No

Notes:

  1. Changes in Significant Subsidiaries during the Period under Review: No

(Changes in specified subsidiaries resulting in a change in the scope of consolidation)

New: ―

Excluded: ―

  1. Changes in Accounting Policies and Changes in Accounting Estimates
    1. Changes in accounting policies that are required under IFRS : Yes
    2. Changes in accounting policies other than 1) above: No
    3. Changes in accounting estimates: No
  2. Number of Shares Issued (Common Stock)
  1. Number of shares issued as of the end of the period (including treasury stock)
  2. Number of treasury stock as of the end of the period
  3. Average number of shares for the period

As of June 30,

13,902,083 shares

As of December

13,860,083 shares

2019

31, 2018

As of June 30,

397 shares

As of December

397 shares

2019

31, 2018

Six months

Six months

ended

13,873,326 shares

ended

13,491,514 shares

June 30, 2019

June 30, 2018

Note: GNI Group consolidated its shares (consolidating 10 shares into 1 share) on July 1, 2018. Average number of shares for the six months ended June 30, 2018 has been calculated assuming consolidation as of January 1, 2018.

* Regarding the Status of Audit Procedure Implementation

This report on the Company's consolidated financial results is not subject to the audit procedures stipulated under the Financial Instruments and Exchange Act of Japan.

* Explanation Concerning the Proper Use of Financial Results Forecasts and Other Relevant Specific Items

Forward-looking statements including earnings forecasts contained in this report are based on currently available information and management's assumptions and beliefs regarding uncertainties that may impact future earnings forecasts. The Company cautions readers that actual results may differ materially from forecasts due to a variety of factors. For the assumptions that underpin financial results forecasts as well as other related items, please refer to "Earnings forecast" on page 6 of this report.

The Company is planning to conduct a corporate presentation meeting for institutional investors and analysts on August 16, 2019. Briefing materials used at that session will be posted on the Company's website as soon as practicable after the meeting.

GNI Group Ltd. (2160) Consolidated Financial Results for Q2 FY2019

Contents

1. Analysis of Operating Results and Financial Position ………………………………………………………………………………

2

(1)

Analysis of operating results ………………………………………………………………………………………………………

2

(2)

Analysis of financial position ………………………………………………………………………………………………………

3

(3)

Research and development activities …………………………………………………………………………………………….

4

  1. Earnings forecast ……………………………………………………………………………………………………………………. 6

2. Summary of Quarterly Consolidated Financial Statements and Notes …………………………………………………………..

7

(1)

Summary of quarterly consolidated statements of financial position ……………………………………………………….

7

(2)

Summary of quarterly consolidated statements of income and summary of quarterly consolidated statements of

8

comprehensive income ………………………………………………………………………………………………………………

Summary of quarterly consolidated statements of income ……………………………………………………………………

8

Summary of quarterly consolidated statements of comprehensive income …………………………………………………

9

  1. Summary of quarterly consolidated statements of changes in equity ………………………………………………………. 10
  2. Summary of quarterly consolidated statements of cash flows ……………………………………………………………….. 12
  3. Notes to the summary of quarterly consolidated financial statements …………………………………………………….. 13

(Notes related to going concern assumptions) …………………………………………………………………………………..

13

(Basis of preparation) ………………………………………………………………………………………………………………

13

(Segment information) ………………………………………………………………………………………………………………

14

(Important subsequent events) ……………………………………………………………………………………………………

16

1

GNI Group Ltd. (2160) Consolidated Financial Results for Q2 FY2019

1. Analysis of Operating Results and Financial Position

Corporate profile

GNI Group Ltd. (GNI Group or the Company) is a multinational pharmaceutical company, headquartered in Tokyo, Japan with the primary business units of pharmaceuticals and biomaterials/medical devices operating via subsidiaries in China and the United States.

In the first six months of FY2019, GNI Group continued to execute its business plan, achieving year-on-year revenue growth, increased profitability and advances in our drug development programs. Our Continental Pharmaceutical Inc. (the Cayman Islands reincorporation of our Beijing Continent Pharmaceuticals Co., Ltd subsidiary) again attained record Etuary® sales in Q2 FY2019. Our Berkeley Advanced Biomaterials LLC medical device business earned higher profitability on a quarter-to-quarter basis compared to FY2018. Moreover, investments continued in our pivotal drug discovery activities at Cullgen Inc. (Cullgen), with support from a USD $16 million capital contribution by two leading global venture capital firms.

Additional key events during the period under review included submission in April of a listing application by Continent Pharmaceuticals Inc. (CPI) to the Stock Exchange of Hong Kong Limited and the approval in May of the Etuary® Investigational New Drug (IND) application by Beijing Continent Pharmaceutical Co, Ltd ("Beijing Continent", CPI's sole operating entity in China) for the treatment of Pneumoconiosis from the National Medical Products Administration (NMPA, formerly CFDA of China).

Provided below is a summary of the GNI Group's consolidated operating results, financial position, cash flows and research and development activities for Q2 FY 2019 from January 1, 2019 to June 30, 2019.

  1. Analysis of operating results

The Company recorded the following consolidated operating results for Q2 FY2019.

Quarterly Consolidated Operating Results Summary

Thousand yen

Q2 FY2018

Q2 FY2019

Difference

Revenue

2,158,783

3,419,440

1,260,656

Gross profit

1,845,173

3,025,150

1,179,976

Operating profit

239,566

681,451

441,884

Quarterly profit (loss)

(6,203)

501,145

507,349

Revenue and gross profit

In Q2 FY2019, Revenue was ¥3,419,440 thousand, an increase of approximately 58.4% over the corresponding period in FY2018. Profit margins improved, with the Gross profit for Q2 FY2019 coming in at ¥3,025,150 thousand, an increase of approximately 63.9% compared with Q2 FY2018. These results were primarily due to record Etuary® sales by Beijing Continent.

Operating profit

In Q2 FY2019, GNI Group's Operating profit was ¥681,451 thousand, an increase of approximately 184.5% over the corresponding period in FY2018. The strong contributions of GNI Group's two business units provided improved margins and operational profitability for the period under review.

Quarterly profit (loss)

For Q2 FY2019, the Company posted a profit of ¥501,145 thousand, an improvement of ¥507,349 thousand compared to a loss of ¥6,203 thousand in Q2 FY2018.

2

GNI Group Ltd. (2160) Consolidated Financial Results for Q2 FY2019

Selling, General and Administrative Expenses; Research and Development Expenses

Thousand yen

Q2 FY2018

Q2 FY2019

Difference

Selling, general and administrative expenses

(1,337,278)

(2,045,143)

(707,864)

Personnel expenses

(648,937)

(756,007)

(107,070)

Research and development expenses

(249,362)

(304,360)

(54,997)

Selling, general and administrative (SG&A) expenses for Q2 FY2019 were ¥2,045,143 thousand, an increase of ¥707,864 thousand compared with Q2 FY2018. The year-on-year increase in SG&A expenses reflects in part costs at Beijing Continent related to the CPI IPO preparations. Research and development expenses increased on a year-on-year basis due to Etuary® new indications and F351 clinical trials, as well as ongoing Cullgen degrader development programs.

Finance Income and Finance Costs

Thousand yen

Q2 FY2018

Q2 FY2019

Difference

Finance income

13,424

31,190

17,766

Finance costs

(188,586)

(108,657)

79,928

Finance income

In Q2 FY2019, GNI Group recorded Finance income of ¥31,190 thousand, an increase of ¥17,766 thousand compared with ¥13,424 thousand in Q2 FY2018.

Finance costs

In Q2 FY2019, GNI Group recorded Finance costs of ¥108,657 thousand, a decrease of ¥79,928 thousand compared with ¥188,586 thousand in Q2 FY2018. The costs in the current quarter mainly reflect non-cash foreign exchange losses from foreign currency- denominated assets and liabilities of the Company and consolidated subsidiaries.

  1. Analysis of financial position

Summary of Consolidated Financial Position

Thousand yen

As of December 31, 2018

As of June 30, 2019

Difference

Total assets

17,100,806

19,063,497

1,962,691

Total liabilities

7,092,869

7,079,745

(13,123)

Total equity

10,007,936

11,983,751

1,975,815

Total assets

As of June 30, 2019, Total assets stood at ¥19,063,497 thousand, an increase of ¥1,962,691 thousand compared with the end of the previous fiscal year.

Total liabilities

As of June 30, 2019, Total liabilities stood at ¥7,079,745 thousand, a decrease of ¥13,123 thousand compared with the end of the previous fiscal year.

Total equity

As of June 30, 2019, Total equity stood at ¥11,983,751 thousand, an increase of ¥1,975,815 thousand compared with the end of the previous fiscal year.

3

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GNI Group Limited published this content on 15 August 2019 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 15 August 2019 06:26:03 UTC