Full Press Release Details
GNI Group Ltd. (2160)
FY2024 Consolidated Financial Results
Consolidated Financial Results for FY2024 (IFRS)
| Company Name: | GNI Group Ltd. | Tokyo Stock Exchange |
| Stock Code: | 2160 | URL https://www.gnipharma.com |
| Representative: | Ying Luo, Director, Representative Executive Officer, President, and CEO | |
| Inquiries: | Toshiya Kitagawa, Director, Executive Officer, and CFO | TEL: +81-3-6214-3600 |
| Annual General Shareholder Meeting Date | March 27, 2025 | |
| Annual financial report (Yuho) disclosure date: | March 31, 2025 | |
| Supplementary materials prepared for financial results: | Yes | |
| Financial result briefing meeting: | Yes (For institutional investors and analysts) (Amounts of less than one million yen are rounded down) |
(Percentages are shown as year-on-year changes)
| Revenue | Operating profit | Pre tax profit | Profit | Profit attributable to owners of parent | comprehensive income | |||||||
| Million yen | % | Million yen | % | Million yen | % | Million yen | % | Million yen | % | Million yen | % | |
| FY2024 | 23,611 | (9.2) | 1,402 | (89.3) | 238 | (98.1) | (130) | - | 977 | (87.9) | 2,268 | (78.7) |
| FY2023 | 26,010 | 49.3 | 13,108 | 851.3 | 12,612 | - | 9,504 | - | 8,094 | - | 10,662 | - |
| Basic earnings per share | Diluted earnings per share | Ratio of profit for the year to equity attributable to owners of parent | Ratio of pre tax profit to total assets | Ratio of operating profit to revenue | |
| Yen | Yen | % | % | % | |
| FY2024 | 19.55 | 18.83 | 2.8 | 0.4 | 5.9 |
| FY2023 | 169.50 | 165.56 | 29.6 | 26.2 | 50.4 |
| Total assets | Total equity | Total equity attributable to owners of parent | Ratio of total equity attributable to owners of parent | Total equity attributable to owners of parent per share | |
| Million yen | Million yen | Million yen | % | Yen | |
| FY2024 | 69,947 | 39,673 | 36,405 | 52.0 | 725.87 |
| FY2023 | 64,269 | 36,504 | 33,794 | 52.6 | 678.01 |
Notes: Provisional accounting treatments for business combinations are being finalized for the fiscal year ending December 2024, and the
figures for the fiscal year ending December 2023 reflect the finalization of the provisional accounting treatments.
| Cash flows from operating activities | Cash flows from investing activities | Cash flows from financing activities | Cash and cash equivalents at end of period | |
| Million yen | Million yen | Million yen | Million yen | |
| FY2024 | (3,164) | (10,361) | 694 | 10,115 |
| FY2023 | 6,549 | (6,842) | 10,686 | 21,633 |
GNI Group Ltd. (2160)
FY2024 Consolidated Financial Results
| Dividends per share | Total amount of dividends | Dividend payout ratio (consolidated) | Ratio of dividend to total equity attributable to owners of parent (consolidated) | |||||
| Q1 | Q2 | Q3 | Year-End | Total | ||||
| Yen | Yen | Yen | Yen | Yen | Million yen | % | % | |
| FY2023 | - | - | - | 0.00 | 0.00 | - | - | - |
| FY2024 | - | - | - | 0.00 | 0.00 | - | - | - |
| FY2025 (Forecast) | - | - | - | 0.00 | 0.00 | - |
(Percentages are shown as year-on-year changes)
| Revenue | Operating profit | Pre-tax profit | Profit for the year | Profit attributable to owners of parent | Basic earnings per share | ||||||
| FY2025 | Million yen | % | Million yen | % | Million yen | % | Million yen | % | Million yen | % | Yen |
| 28,733 | 21.7 | 23,217 | - | 22,541 | - | 15,868 | - | 12,058 | - | 240.42 |
For details regarding the performance forecasts above, please refer to the attached document "1. Analysis of Operating Results and
Financial Position (5) Outlook for the Fiscal Year Ending December 31,2025"
| Number of shares issued as of the end of the period (including treasury shares) | FY2024 | 50,168,243 shares | FY2023 | 49,857,243 shares | ||
| Number of treasury shares as of the end of the period | FY2024 | 13,550 shares | FY2023 | 13,526 shares | ||
| Average number of shares for the period | FY2024 | 50,007,923 shares | FY2023 | 47,752,120 shares |
GNI Group Ltd. (2160)
FY2024 Consolidated Financial Results
| 1. | Analysis of Operating Results and Financial Position | 2 | |
| (1) | Analysis of Operating Results | 2 | |
| (2) | Analysis of Financial Position | 4 | |
| (3) | Analysis of Cash Flows | 4 | |
| (4) | Research and Dvelopment Ativities | 5 | |
| (5) | Outlook for the Fiscal Year Ending December 31, 2025 | 6 | |
| 2. | Basic Policy on the Selection of Accounting Standards | 6 | |
| 3. | Consolidated Financial Statements and Notes | 7 | |
| (1) | Consolidated Statements of Financial Position | 7 | |
| (2) | Consolidated Statements of Income and Consolidated Statements of Comprehensive Income | 9 | |
| (3) | Consolidated Statements of Changes in Equity | 11 | |
| (4) | Consolidated Statements of Cash Flows | 13 | |
| (5) | Notes to the Consolidated Financial Statements | 15 | |
| (Notes Related to Going Concern Assumptions) | 15 | ||
| (Basis of Preparation) | 15 | ||
| (Segment Information) | 19 | ||
| (Earnings Per Share) | 19 | ||
| (Important Subsequent Events) | 19 |
GNI Group Ltd. (2160)
FY2024 Consolidated Financial Results
In 2024, the global economy remained uncertain due to high geopolitical risks such as the prolonged Russian invasion
of Ukraine and instability in the Middle East. In Japan, the Nikkei average stock price has recorded its first 40,000 yen level, and a certain level of growth is being seen against the backdrop of a solid employment environment and a recovery in
tourism demand. However, currency volatility has increased, and price inflation has been driven by rising import costs. On the other hand, the pace of wage increases continues to be unable to keep up with rising prices, and reducing the burden on
households and addressing sustainable economic growth have become issues. As for the biotechnology sector to which our company belongs and the Tokyo Stock Exchange Growth Market, the situation is not entirely optimistic due to concerns over continued
interest rate hikes in Japan.
Under these circumstances, GNI Group Co., Ltd. ("the Company" or "we") and its affiliated companies ("the Group") have
been steadily promoting projects such as research and development, which the Group has been working on as a stepping stone to future business development, and the listing of subsidiary Cullgen Inc. ("Cullgen"), which have been undertaken by the Group
as a whole, in order to become a global mid-sized pharmaceutical company.
In the pharmaceutical and drug discovery Segments, Beijing Continent Pharmaceuticals Co., Ltd. (doing business as Gyre
Pharmaceuticals Co., Ltd. "Gyre Pharmaceuticals"), a major subsidiary of the Group, maintained total annual sales of its main product, ETUARY , at the same level as last year, despite the anti-corruption campaign in the PRC lasting longer than
expected. In order to gain a strong position in the pulmonary fibrosis field, we acquired the rights to manufacture and sell Nintedanib, which is indicated for pulmonary fibrosis other than Idiopathic Pulmonary Fibrosis (IPF) in May 2024.
Furthermore, in the rare disease field (orphan drugs), Gyre Pharmaceuticals received manufacturing and commercial approval in June 2024 for avatrombopag maleate tablets, a treatment for thrombocytopenia due to chronic liver disease that it had been
developing in the PRC and in January 2025, approval was granted for an expanded indication to include ITP (chronic idiopathic thrombocytopenia). As a result, it is expected that future sales revenue will increase by utilizing the existing sales
In October 2024, Gyre Pharmaceuticals completed the Phase 3 clinical trial in the PRC for F351, a promising candidate
for the next product, targeting liver fibrosis caused by hepatitis B, and is working diligently to disclose top-line data from the clinical trial. In addition, Gyre Pharmaceuticals is exploring its future global expansion as a treatment for liver
fibrosis caused by MASH (metabolic dysfunction-associated steatohepatitis).
As disclosed on November 14, 2024, Cullgen, a U.S. subsidiary that conducts research and development of innovative new
drugs mainly in the U.S. and the PRC, announced that it will become a listed company on the Nasdaq market in the U.S. through a reverse merger. If successfully listed, it will be the second public company after Gyre Therapeutics.
Cullgen continues to advance drug discovery using its proprietary uSMITE (ubiquitin-mediated, small molecule induced
target elimination) targeted protein degradation inducer technology platform. Cullgen has signed a joint research and option agreement with Astellas Pharma Inc. ("Astellas Pharma") to create innovative protein degradation inducers, and the joint
research with Astellas Pharma in this strategic alliance is progressing smoothly.
Cullgen is currently conducting clinical trials in the PRC for CG001419 (development number) as the Company's first
TRK degrader anticancer drug candidate, and has begun Phase 1/2 clinical trials. In addition, Cullgen established a subsidiary in Australia, its third country after the PRC and the U.S., and began the Phase 1 clinical trial for acute and chronic pain
in January 2025. Moreover, as disclosed on October 9, 2024, the IND (Investigational New Drug Application) for CG009301 (development number), a treatment for malignant hematological tumors (leukemia) being developed in the PRC and the U.S. has been
approved. Research and development are also underway for several other programs with the aim of starting clinical trials.
Pharmaceutical Segment
The revenue of the main product of Gyre Pharmaceuticals, ETUARY , remained steady in the Chinese market. Cullgen recorded revenue of
JPY1,438 million from the joint development of targeted protein degraders with Astellas Pharma. As a result, the current consolidated fiscal year in the pharmaceutical segment, revenue and segment profit were JPY 18.3 billion down 20.3% YoY, and
JPY0.3 billion, down 96.9% YoY, respectively. However, the segment profit remained steady, excluding a one-time revenue of upfront license fee from Astellas Pharma, and valuation gain on Gyre Therapeutics shares, both incurred in FY2023.
Medical Device Segment
In the Medical Device Segment, due to the inclusion of the newly established subsidiary in the consolidation last year, the segment revenue
was JPY 5,307 billion, up 73.5% YoY, and the segment profit was JPY 10 billion, down 4.7% YoY, respectively.
GNI Group Ltd. (2160)
FY2024 Consolidated Financial Results
| FY2023 | FY2024 | Difference | |
| Selling, general and administrative expenses | (15,292,839) | (15,771,868) | (479,029) |
| Personnel expenses | (5,318,748) | (5,074,682) | 244,065 |
| Research and development expenses | (2,557,803) | (2,811,801) | (253,998) |
Selling, general and administrative (SG&A) expenses for FY2024 were JPY 15.7 billion, up 3.1% YoY.
Research and development (R&D) expenses for FY2024 were JPY 2.8 billion, up 9.9% YoY. The increase in R&D expenses was mainly due
to the progress of preclinical and clinical trials at Cullgen.
| FY2023 | FY2024 | Difference | |
| Finance income | 771,527 | 707,799 | (63,728) |
| Finance costs | (1,250,685) | (1,880,621) | (629,935) |
Finance income for FY2024 was JPY 707 million, down 8.3% YoY. This decrease of Finance Income was mainly due to decreased foreign exchange
Finance costs for 2024 was JPY 1,880 million, up 50.4% YoY. This increase was mainly due to increased foreign exchange losses and non-cash
interest expense related to Cullgen financing.
GNI Group Ltd. (2160)
FY2024 Consolidated Financial Results
of Financial Position
The provisional accounting treatment for the business combination carried out in the previous consolidated fiscal year
was finalized in this consolidated fiscal year. In accordance with the finalization of this provisional accounting treatment, the comparative information included in the consolidated financial statements for this consolidated fiscal year reflects a
review of the initial allocation of the acquisition cost, and for comparison and analysis with the end of the previous consolidated fiscal year, the amount based on the final amount after reflecting this review is used.
Summary of Consolidated Financial Position
| As of December 31, 2023 | As of December 31, 2024 | Difference | |
| Total assets | 64,269,302 | 69,947,020 | 5,677,718 |
| Total liabilities | 27,764,834 | 30,273,460 | 2,508,625 |
| Total equity | 36,504,467 | 39,673,560 | 3,169,092 |
As of FY 2024 year-end, total assets stood at 69.9 billion, up 8.8% compared to the previous fiscal year end. This increase in total
assets was mainly due to an increase in Non-current Intangible Assets.
As of FY 2024 year-end, total liabilities stood at 30.2 billion, up 9.0% compared to the previous fiscal year end. This increase in total
liabilities was mainly due to an increase in short-term borrowings.
As of FY 2024 year-end, total equity stood at 39.6 billion, up 8.7% compared to the previous fiscal year end. This increase decrease was
mainly due to increased other components of equity.
(3) Analysis of Cash Flows
Summary of Consolidated Cash Flows
| FY2023 | FY2024 | Difference | |
| Cash flows from operating activities | 6,549,337 | (3,164,422) | (9,713,759) |
| Cash flows from investing activities | (6,842,661) | (10,361,330) | (3,518,669) |
| Cash flows from financing activities | 10,686,556 | 694,161 | (9,992,394) |
Cash flows from operating activities
The cash flow from operating activities was 3.1 billion (cash outflow) in FY2024 (it was 6.5 billion cash inflow in FY2023). This outflow
of cash was mainly due to increased payment of corporate income taxes.
Cash flows from investing activities
The cash flow from investing activities was 10.3 billion (cash outflow) in FY2024 (it was 6.8 billion cash outflow in FY2023). This was
mainly due to an increase in leasehold and guarantee deposits and the purchase of securities.
Cash flows from financing activities
The cash flow from financing activities was 0.6 billion (cash inflow) in FY2024 (it was 10.6 billion cash inflow in FY2023). This was
mainly due to an increase in short-term borrowings, and inflow from capital contribution from non-controlling interests.
GNI Group Ltd. (2160)
FY2024 Consolidated Financial Results
(4) Research and Dvelopment Ativities
[Research Activities]
The Group's drug discovery research aims to develop innovative new candidate compounds (NCEs) centered around Cullgen. Cullgen is conducting research and development to expand its drug discovery pipeline, which includes multiple novel compounds
targeting enzyme and non-enzyme proteins for cancer, pain, and autoimmune diseases.
In June 2023, Cullgen entered into a collaboration
and exclusive option agreement with Astellas Pharma to create innovative protein degradation inducers. In this strategic alliance, the two companies will combine Cullgen's proprietary technology platform uSMITE utilizing novel E3 ligands with