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GNI Group Ltd. (JP:2160)
:2160

GNI Group (2160) AI Stock Analysis

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JP:2160

GNI Group

(2160)

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Neutral 52 (OpenAI - 5.2)
Rating:52Neutral
Price Target:
¥2,640.00
▲(15.28% Upside)
Action:ReiteratedDate:02/18/26
Overall score is held back primarily by weak recent profitability and continued cash burn (2024–2025), despite a relatively conservative balance sheet. Technicals are modestly supportive in the near term, but the negative P/E underscores earnings risk.
Positive Factors
Conservative balance sheet
Low debt-to-equity (~0.13 in 2025) and a conservative leverage profile give the company durable financial flexibility. This reduces refinancing risk and supports multi-quarter funding of R&D or operations, improving resilience to biotech cyclicality and execution delays.
Sustained revenue growth and high gross margins
A multi-year revenue growth trend and persistently very high gross margins indicate strong core economics and pricing power. High gross margins provide a structural buffer to absorb SG&A or R&D spend while enabling margins to recover if operating costs are reined in.
Growing asset and equity base
Material equity and asset expansion strengthens solvency and funds strategic initiatives without immediate reliance on heavy external debt. A larger equity base improves the company's ability to invest in capex, R&D, or partnerships over the medium term.
Negative Factors
Persistent cash burn
Consecutive years of negative operating and free cash flow mean the business is not self-funding. Ongoing cash burn elevates funding risk, may force dilution or debt raises, and limits the firm's capacity to sustain R&D or commercialization without external capital.
Profitability collapse in 2025
A meaningful swing to operating and net losses in 2025 erodes earnings quality and reduces visibility into future margins. Such a sharp profitability reversal suggests structural cost or revenue issues that could persist absent clear remediation.
Volatile earnings and execution risk
An extreme EPS decline (~-486%) combined with cash-flow swings from strong 2023 to negative 2024–25 indicates volatile execution. This raises the probability of uneven recovery, potential financing needs, and execution risk for long-term product or pipeline commercialization.

GNI Group (2160) vs. iShares MSCI Japan ETF (EWJ)

GNI Group Business Overview & Revenue Model

Company DescriptionGNI Group Ltd. engages in the research, development, manufacture, and sale of pharmaceutical drugs and traditional Chinese medicines in Japan and internationally. It provides Etuary for the treatment of idiopathic pulmonary fibrosis. The company is also developing Etuary, which is in Phase III clinical trial for the treatment of connective tissue associated interstitial lung disease; and in clinical trial phase II and pre-phase III clinical trial pilot study for the treatment of radiation pneumonitis, as well as for the treatment of diabetic nephropathy. In addition, it is involved in developing F351, which is in Phase II clinical trial for the treatment of liver fibrosis; and F573 that is in pre-clinical phase for the treatment of acute on chronic liver failure, as well as Tamibarotene for the treatment of acute promyelocytic leukemia. GNI Group Ltd. was incorporated in 2001 and is headquartered in Tokyo, Japan.
How the Company Makes MoneyGNI Group generates revenue primarily through the sale of its biopharmaceutical products and services, including the production of active pharmaceutical ingredients (APIs) for various therapeutic areas. The company's revenue model is bolstered by long-term contracts and collaborations with major pharmaceutical companies, which provide a steady stream of income. Additionally, GNI Group benefits from research and development partnerships that enhance its product offerings and market reach. The company may also earn revenue from licensing agreements and royalties associated with its proprietary technologies and innovations in the biotech field.

GNI Group Financial Statement Overview

Summary
Financials are mixed: the balance sheet is relatively strong with low leverage, but 2025 profitability deteriorated sharply (swing to operating and net losses) and cash flow is a key concern with negative operating cash flow and free cash flow in both 2024 and 2025.
Income Statement
52
Neutral
Revenue has grown over the long run (2020–2025), including a solid rebound in 2025 (+4.1%), but growth has been volatile with a decline in 2024. Profitability deteriorated sharply in 2025: operating profit and net income swung to meaningful losses after strong 2023 profitability. Gross margins remain very high, but the recent collapse in operating and net margins suggests elevated operating costs and/or non-recurring pressure, reducing earnings quality and visibility.
Balance Sheet
74
Positive
Leverage appears conservative with low debt relative to equity (debt-to-equity ~0.13 in 2025), and equity has grown materially versus earlier years, supporting balance sheet resilience. Total assets have also expanded steadily. The main weakness is shareholder returns turning negative in 2025 as losses emerged, which can pressure capital efficiency if profitability does not recover.
Cash Flow
35
Negative
Cash generation weakened materially: operating cash flow and free cash flow were negative in both 2024 and 2025, indicating the business is not currently self-funding. This contrasts with strong positive cash flow in 2023, highlighting volatility. While free cash flow decline moderated in 2025 versus 2024 (growth rate positive), the continued cash burn alongside net losses elevates funding and execution risk.
BreakdownDec 2025Dec 2024Dec 2023Dec 2022Dec 2021
Income Statement
Total Revenue26.84B23.61B26.01B17.42B12.69B
Gross Profit19.99B18.04B22.43B14.74B11.09B
EBITDA-1.17B2.39B14.49B2.16B2.14B
Net Income-4.41B977.66M8.09B388.82M1.07B
Balance Sheet
Total Assets83.79B71.94B62.39B33.91B30.30B
Cash, Cash Equivalents and Short-Term Investments21.10B12.93B23.15B11.25B14.36B
Total Debt6.36B7.21B3.70B537.36M1.13B
Total Liabilities32.11B32.23B26.34B14.10B11.03B
Stockholders Equity50.15B36.45B33.79B20.97B18.86B
Cash Flow
Free Cash Flow-2.74B-3.69B4.47B-1.55B-142.13M
Operating Cash Flow-2.41B-3.16B6.55B393.32M552.27M
Investing Cash Flow2.73B-10.36B-6.84B-4.12B-260.64M
Financing Cash Flow10.47B694.16M10.69B-646.33M2.85B

GNI Group Technical Analysis

Technical Analysis Sentiment
Positive
Last Price2290.00
Price Trends
50DMA
2562.88
Positive
100DMA
2500.09
Positive
200DMA
2768.11
Positive
Market Momentum
MACD
111.35
Negative
RSI
71.93
Negative
STOCH
83.37
Negative
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For JP:2160, the sentiment is Positive. The current price of 2290 is below the 20-day moving average (MA) of 2664.80, below the 50-day MA of 2562.88, and below the 200-day MA of 2768.11, indicating a bullish trend. The MACD of 111.35 indicates Negative momentum. The RSI at 71.93 is Negative, neither overbought nor oversold. The STOCH value of 83.37 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for JP:2160.

GNI Group Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
55
Neutral
¥27.57B-61.60-5.65%-469.19%
52
Neutral
¥160.15B-34.93-1.81%13.78%-110.02%
52
Neutral
¥82.26B-6.76-9.05%-1.96%-64.18%
52
Neutral
¥138.24B-19.182.18%-0.16%-802.20%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
48
Neutral
¥169.33B-44.05-636.97%-12.69%
46
Neutral
¥174.10B-48.22-10.16%-62.47%-134.06%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
JP:2160
GNI Group
3,160.00
-215.00
-6.37%
JP:4587
Peptidream
1,425.50
-610.00
-29.97%
JP:4592
SanBio Co
2,258.00
1,137.00
101.43%
JP:4565
Sosei Group
966.00
118.00
13.92%
JP:4974
Takara Bio Inc.
1,147.00
319.55
38.62%
JP:7774
Japan Tissue Engineering Co., Ltd.
796.00
287.00
56.39%

GNI Group Corporate Events

GNI Group Swings to Non-Consolidated Loss on Absence of One-Off Gain and Forward Transaction Hit
Feb 13, 2026

GNI Group Ltd., a biopharmaceutical company listed on the TSE Growth market, reported a sharp year-on-year swing in its non-consolidated performance for the fiscal year ended December 31, 2025, under Japanese GAAP. The company’s standalone results are sensitive to intragroup transactions, particularly with its U.S. subsidiaries, which can create substantial temporary gains or losses that differ from the underlying operating picture.

For 2025, GNI’s non-consolidated ordinary income fell to a loss of JPY 1.59 billion and net income dropped to a loss of JPY 1.33 billion, compared with profits of JPY 5.90 billion in the previous year, with net income per share reversing from JPY 118.06 to a loss of JPY 25.45. Management attributed the decline mainly to the absence of a prior one-off gain from the reversal of about JPY 6.02 billion in doubtful-account provisions tied to GNI USA and Gyre Therapeutics shares, and to a new one-time loss of JPY 630 million on a forward transaction, highlighting the impact of non-recurring items on the company’s headline earnings for investors and other stakeholders.

The most recent analyst rating on (JP:2160) stock is a Hold with a Yen2600.00 price target. To see the full list of analyst forecasts on GNI Group stock, see the JP:2160 Stock Forecast page.

GNI Group Swings to Loss in FY2025 Despite Higher Revenue and Stronger Equity Base
Feb 13, 2026

GNI Group reported FY2025 consolidated revenue of ¥26.84 billion, up 13.7% year on year, but swung to an operating loss of ¥3.48 billion and a loss attributable to owners of the parent of ¥4.41 billion, reversing the prior year’s profit. Despite the loss, total assets rose to ¥83.79 billion and equity attributable to owners increased to ¥50.15 billion, reflecting strengthened capital, while the company again withheld dividends and refrained from issuing an FY2026 earnings forecast due to difficulty in reasonably estimating performance in its pharmaceutical and drug discovery businesses.

The most recent analyst rating on (JP:2160) stock is a Hold with a Yen2600.00 price target. To see the full list of analyst forecasts on GNI Group stock, see the JP:2160 Stock Forecast page.

GNI Group Delays 2026 Earnings Forecast Amid Regulatory and Pipeline Uncertainty
Feb 13, 2026

GNI Group has postponed the disclosure of its full-year 2026 consolidated earnings forecast and related earnings presentation materials, as well as an earnings briefing that had been scheduled for February 24, 2026. The company cites both regulatory constraints linked to its U.S.-listed subsidiary Gyre Therapeutics, whose own results are due in mid-March, and the difficulty of reasonably estimating key variables affecting 2026 performance.

Management says detailed segment and outlook information is tightly connected to Gyre Therapeutics’ performance, and early disclosure in Japan could raise concerns under U.S. fair disclosure rules. In addition, earnings are highly sensitive to the approval timing, launch schedule, and pricing of F351 and to R&D progress at Cullgen, making forecasts currently unreliable and therefore classified as undetermined.

The decision reflects a revised disclosure policy as F351 enters a pivotal phase toward a planned NDA submission in the first half of 2026, with the company emphasizing strict information control aligned with global standards. GNI argues that prioritizing compliance and governance around this first-in-class drug candidate will support long-term shareholder value, and it plans to release materials and forecasts once Gyre’s announcement is complete and reasonable estimates are possible.

The most recent analyst rating on (JP:2160) stock is a Hold with a Yen2600.00 price target. To see the full list of analyst forecasts on GNI Group stock, see the JP:2160 Stock Forecast page.

GNI Group Explains Acquisition Plans, Earnings Revision and F351 Disclosure Strategy
Feb 12, 2026

GNI Group has addressed a series of investor questions to enhance transparency around its strategy and disclosure practices, notably regarding the planned acquisition of Gyre Pharmaceuticals funded by its July 2025 overseas offering. The company aims to complete the deal by the end of 2026 but stresses that timing and capital allocation may shift depending on negotiations and the relative growth potential of other projects, with shareholder value as the primary consideration.

Management also defended the timing of its revised full-year earnings forecast, explaining that late-year external changes, the material impact of subsidiary Cullgen, and year-end asset impairment testing delayed finalization until after December 31. In addition, GNI clarified its communications on F351, stating it avoids repeating previously disclosed details, and outlined general definitions around F351’s target indication and regulatory process, while emphasizing that detailed interactions with regulators remain confidential under standard pharmaceutical industry practice.

The most recent analyst rating on (JP:2160) stock is a Hold with a Yen2600.00 price target. To see the full list of analyst forecasts on GNI Group stock, see the JP:2160 Stock Forecast page.

GNI Group Slashes 2025 Profit Outlook as Cullgen Listing Is Delayed and Impairment Losses Loom
Jan 23, 2026

GNI Group has sharply revised its full-year 2025 consolidated earnings forecast, now projecting lower revenue of ¥26.8 billion and a swing from a previously expected substantial profit to a net loss, driven mainly by the deferral of the planned NASDAQ listing of core biotech subsidiary Cullgen and the exclusion of an anticipated large listing gain. The company will also recognize an impairment loss of ¥468 million on goodwill, intangible and fixed assets tied to several subsidiaries, while Cullgen’s full-year operating loss will remain fully consolidated instead of shifting to equity-method accounting, further pressuring earnings even as ETUARY® and the Medtech unit continue to post record-high revenues, implying a near-term hit to profitability and equity story despite ongoing operational growth in its core businesses and continued pursuit of Cullgen’s listing.

The most recent analyst rating on (JP:2160) stock is a Hold with a Yen2406.00 price target. To see the full list of analyst forecasts on GNI Group stock, see the JP:2160 Stock Forecast page.

GNI Group Makes Dental Lab ZOO LABO a Consolidated Subsidiary to Bolster Japan Medtech Base
Jan 9, 2026

GNI Group has acquired all shares of dental laboratory operator ZOO LABO, Inc., converting it into a consolidated subsidiary as of 29 December 2025, in a move to strengthen and expand its business base in Japan beyond headquarters functions. By integrating ZOO LABO’s CAD/CAM-driven dental prosthetics manufacturing with its existing Medtech capabilities and dental-use bone materials from Berkeley Advanced Biomaterials, GNI aims to accelerate digitalization in the dental field, create group synergies and enhance its medium- to long-term earnings, though the immediate impact on fiscal 2025 results is expected to be limited, with consolidation of ZOO LABO’s financials beginning in 2026.

The most recent analyst rating on (JP:2160) stock is a Hold with a Yen2443.00 price target. To see the full list of analyst forecasts on GNI Group stock, see the JP:2160 Stock Forecast page.

GNI Subsidiary Cullgen to Showcase Advancing Pipeline at J.P. Morgan Healthcare Conference
Jan 7, 2026

GNI Group’s U.S.-based consolidated subsidiary Cullgen Inc. will participate in the 44th Annual J.P. Morgan Healthcare Conference in San Francisco, one of the industry’s most prominent investor events that convenes global healthcare executives and institutional investors. Alongside this appearance, Cullgen has published an updated corporate presentation outlining key pipeline progress, including plans to start a Phase 2 clinical trial in the second quarter of 2026 for its novel non-opioid pain candidate CG001419 and the advancement of a new targeted protein degrader program for inflammatory diseases into IND-enabling studies, developments that underscore the group’s push to expand its clinical-stage portfolio and raise its profile with international investors.

The most recent analyst rating on (JP:2160) stock is a Hold with a Yen2443.00 price target. To see the full list of analyst forecasts on GNI Group stock, see the JP:2160 Stock Forecast page.

GNI Group’s F351 Secures Path Toward Conditional Approval and Priority Review in China
Jan 5, 2026

GNI Group announced that its subsidiary Gyre Therapeutics has completed a Pre-New Drug Application meeting with China’s Center for Drug Evaluation regarding F351, confirming that an NDA submission via the conditional approval pathway is acceptable and that the drug may qualify for Priority Review. F351, already designated a Breakthrough Therapy by Chinese regulators, is now positioned for an NDA filing in the first half of 2026, with Gyre preparing a confirmatory clinical trial to support the potential transition from conditional to full approval, a step that could accelerate time to market and strengthen the company’s position in the hepatology drug space in China.

The most recent analyst rating on (JP:2160) stock is a Hold with a Yen2311.00 price target. To see the full list of analyst forecasts on GNI Group stock, see the JP:2160 Stock Forecast page.

GNI Group Exits Governance Partners ASIA Fund and Brings Key Holding On-Balance Sheet
Dec 22, 2025

GNI Group has decided to withdraw from Governance Partners ASIA Limited Partnership, a fund it had treated as a consolidated subsidiary, ending its equity relationship and removing the vehicle from its scope of consolidation. The move is part of a broader effort to streamline investment management and review the group’s ownership structure, with 4 million shares of Japan Asia Investment Co., Ltd. that were held by the fund to be distributed in kind so that GNI Group will hold them directly, a change the company expects will have only an immaterial impact on its fiscal 2025 consolidated results.

The most recent analyst rating on (JP:2160) stock is a Hold with a Yen2311.00 price target. To see the full list of analyst forecasts on GNI Group stock, see the JP:2160 Stock Forecast page.

GNI Subsidiary Cullgen and Pulmatrix Relax Merger Terms to Seek Strategic Alternatives
Dec 18, 2025

GNI Group announced that its major subsidiary Cullgen Inc. and U.S.-listed Pulmatrix, Inc. have mutually waived the “no solicitation” clause in their reverse merger agreement intended to facilitate Cullgen’s Nasdaq listing. The change allows both parties to keep pursuing regulatory approval for the merger from the China Securities Regulatory Commission while simultaneously exploring alternative strategic transactions that could be more advantageous, signaling flexibility in dealmaking and potential changes to Cullgen’s route to international capital markets if CSRC approval continues to be delayed.

The most recent analyst rating on (JP:2160) stock is a Hold with a Yen2311.00 price target. To see the full list of analyst forecasts on GNI Group stock, see the JP:2160 Stock Forecast page.

GNI Group’s Subsidiary Reports Positive Phase 1 Trial Results for Non-Opioid Pain Treatment
Dec 14, 2025

GNI Group’s subsidiary, Cullgen Inc., has successfully completed a Phase 1 clinical trial for CG001419, a promising non-opioid pain treatment. The trial showed that the drug was well tolerated without serious adverse effects, paving the way for a Phase 2 trial in the U.S. in 2026, potentially positioning the company as a leader in non-opioid analgesics.

The most recent analyst rating on (JP:2160) stock is a Hold with a Yen2311.00 price target. To see the full list of analyst forecasts on GNI Group stock, see the JP:2160 Stock Forecast page.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Feb 18, 2026