Slide 1: GNI Group Ltd. FY2024 Full Year Financial Results
GNI Group Ltd. FY2024 Full Year Financial Results Corporate Presentation Reference Translation Securities Code: 2160
Slide 2: We Bring New Hope to Life
We Bring New Hope to Life. © 2025 GNI Group Ltd. All rights reserved Reference Translation 1
Slide 3: Agenda
Agenda 1. Company Overview 2. Financial Highlights 3. FY2024 Topics 4. Financial forecast for FY2025 5. FY2025 Topics 6. GNI Group’s Value Proposition 7. Supplementary Materials © 2025 GNI Group Ltd. All rights reserved Reference Translation 2
Slide 4: 1. Company Overview
1. Company Overview © 2025 GNI Group Ltd. All rights reserved Reference Translation 3
Slide 5: Company Overview
Company Overview Head Office Main Business 3rd Floor, Nihonbashi Honcho YS Building, Global pharmaceutical R&D, 2-2-2, Nihonbashi-Honcho manufacturing and distribution, Chuo-ku, Tokyo 103-0023 and biomaterials business Incorporation Director, Representative Executive November 2001 Officer, President
Slide 6: Ying Luo Ph.D., Director, Representative Executive Officer, President, and CEO
Director, Representative Executive Officer, President, and CEO Ying Luo Ph.D. • As a Chinese-American, he pioneered the new profitable business model that leverages the unique strengths of the pharmaceutical industry in the PRC, the U.S., and Japan in developing new therapeutic products for unmet me
Slide 7: Business model: Pharmatech, Biotech, Medtech
Business model Pharmatech Biotech Medtech (Biomaterials) Name Gyre Therapeutics,Inc. Berkeley Advanced Biomedicals LLC (BAB) Cullgen Inc. Gyre Pharmaceuticals Berkeley Biologics LLC (BB) • Listed on NASDAQ • Listing announcement (November 14) • Conducted an M&A in 2023 • Development of anti-fibrotic
Slide 8: Major Pharmaceutical & Drug Discovery
Major Pharmaceutical & Drug Discovery ＜Pharmaceutical＞ ETUARY®（Generic name：Pirfenidone） ・Chinese：艾思瑞、English：ETUARY® ・Treatment for idiopathic pulmonary fibrosis (IPF) and market leader in the PRC ・Clinical developments are underway for expansion of indications（Three Phase３trials） ・Donating to NPO
Slide 9: Who we are (1): From Drug Discovery Success to Commercialization
Who we are (1) From Drug Discovery Success to Commercialization (100 million yen) ETUARY® Sales 200 156 157 150 129 97 100 69 50 50 28 16 0 2017 2018 2019 2020 2021 2022 2023 2024 © 2025 GNI Group Ltd. All rights reserved Reference Translation 8
Slide 10: Who we are (2): A Rare Drug Development Company
Who we are (2) A Rare Drug Development Company With Commercialization Capability and Operating Profit ■ Operating profit before R&D* (left axis) ー Revenue (right axis) (Millions of yen) 30000 40,000 25000 30,000 20000 15,666 15000 20,000 10000 10,000 5000 3,640 3,923 4,203 3,112 2,060 422 1,098 0 0
Slide 11: Who we are (3): Globally recognized for high development capabilities
Who we are (3) Globally recognized for high development capabilities Successful development of ETUARY® Completed Phase 3 trial for F351* Ongoing large-scale joint research with Astellas Pharma Investment let by AstraZeneca into Cullgen with one board seat © 2025 GNI Group Ltd. All rights reserved Re
Slide 12: Listed Subsidiaries is GNI's Strategy for Value Realization and Global Expansion
Who we are (4) Listed Subsidiaries is GNI’s Strategy for Value Realization and Global Expansion 1. GYRE’s successful listing on NASDAQ enables Japanese shareholders to see the value of our strong presence in China 2. Cullgen will be our second in pipeline to give GNI’s expansion on global stage 3. M
Slide 13: GNI Group is a group company that operates globally
GNI Group is a group company that • Operates globally in the U.S. and China as well as Japan. • Demonstrates world-class development capabilities while succeeding in drug discovery and making profits as a pharmaceutical manufacturer. • Accelerates further new drug development and realizes huge growt
Slide 14: Growth stock and value stock
In other words, As a Growth stock, we will continue our strong curve of growth in the coming years, especially after F351 commercialization. As a Value stock, we will deliver values to our shareholders through individual listing of our strong subsidiaries. © 2025 GNI Group Ltd. All rights reserved R
Slide 15: 2. Financial Highlights
2. Financial Highlights © 2025 GNI Group Ltd. All rights reserved Reference Translation 14
Slide 16: Differences in financial results due to postponement of fiscal year
Forecast for 2024 Differences in financial results due to postponement of fiscal year FY2024 FY2024 Reason Forecast Actual Millions of yen M&A projects that were expected to be highly Revenue 39,556 23,611 feasible were postponed Gross profit 34,624 18,037 Postponement of listing gain due to Cullgen
Slide 17: Consolidated income summary
Consolidated income summary Steady growth for the Group as a whole, excluding an upfront payment 4.92 billion last year Q4 FY2023 Inc. / (Dec.) Q4 FY2023 Q4 FY2024 (excluding one-time Inc. / (Dec.) (excluding one-time Cumulative total Cumulative total Millions of yen payments*) payments*) Revenue 26
Slide 18: Result of Stock Price Reservation Trading Program
Result of Stock Price Reservation Trading Program Contributed to earnings with a full-year positive impact Profit and Support to GNI Shareholders FY2024 4Q Full-year Other expences (Stock valuation gain) Stock valuation gain related to stock forward 573 million yen 119 million yen contract with Macq
Slide 19: Consolidated balance sheet summary
Consolidated balance sheet summary FY2021 End FY2022 End FY2023 End Q4 FY2024 Inc. / (Dec.) Millions of yen Actual Actual Actual Cumulative total Total non-current assets 12,109 16,759 33,475 40,724 17.8% Total current assets 18,187 17,147 30,793 29,222 (5.4)% Total assets 30,296 33,906 64,269 69
Slide 20: Sufficient cash
Sufficient cash Shares of listed subsidiary GYRE are Cash Equivalent assets Future addition of shares of Cullgen and Medtech Group expected 2024 Q4 160.2 billion yen Cash-equivalent assets 2024 Q4 Cash and cash equivalents 14.31 billion yen Time Deposits 2.81 billion yen Market Value of Gyre Shareho
Slide 21: R&D expenses
R&D expenses Steady progress in drug development FY2021 FY2022 FY2023 Q4 FY2024 Actual Actual Actual Cumulative total (Millions of yen) Consolidated R&D expenses 2,015 2,545 2,557 2,811 Capitalized development costs 336 606 940 1,165 Total 2,351 3,151 3,497 3,976* *14% YoY increase © 2025 GNI Group
Slide 22: 3. FY2024 Topics
3. FY2024 Topics © 2025 GNI Group Ltd. All rights reserved Reference Translation 21
Slide 23: Progress of Featured Events
FY2024 Topic GNI group Progress of Featured Events Events Progress Details Clinical trials １．Received results of Phase 3 clinical trial of F351 Waiting for top line data to be released. completed ２．Cullgen's listing Announced Listing announced. to be listed in 2025. Two new products will contribute
Slide 24: Expansion of pharmaceutical sales lineup
FY2024 Topic [Pharmatech] Expansion of pharmaceutical sales lineup Product Indication Present IPF Production and sales rights acquired systemic sclerosis-associated interstitial lung Nintedanib disease (SSc-ILD) (May 2024) progressive fibrotic interstitial lung disease (PF-ILD) Thrombocytopenia due
Slide 25: Steady sales of key products in challenging Chinese economic environment
FY2024 Topic [Pharmatech] Steady sales of key products in very challenging Chinese economic environment ETUARY® Sales Quarterly sales 15.7 billion yen (Billion yen) 156 157 44.8 129 41.7 40.1 40.3 97 37.9 37.4 38 33.4 69 50 28 16 2017 2018 2019 2020 2021 2022 2023 2024 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 FY2023
Slide 26: Completion of Phase 3 clinical trial for F351
FY2024 Topic [Pharmatech] Completion of Phase 3 clinical trial for F351 About F351 • The drug with the potential to become the first treatment for approximately 150 million liver fibrosis patients in China =Potential blockbuster drug • Designated as a "breakthrough therapy" by the NMPA • Considerin
Slide 27: New Blockbuster Pipeline Starts with Pain as Indication
FY2024 Topic [Biotech] New Blockbuster Pipeline Starts with Pain as Indication ①IND application approval－October 2024 • CG009301（GSPT1 protein-targeting decomposition drug） • Indication: Malignant blood tumors(leukemia) • Third IND application approval following TRK ②Phase 1 clinical trial －from Jan
Slide 28: Cullgen's listing announcement
FY2024 Topic [Biotech] Cullgen's listing announcement Rapid listing through merger with PULMATRiX, Inc. a NASDAQ listed company The second listing of GNI subsidiaries following GYRE Increase in awareness and credibility + Promotion of future new drug development © 2025 GNI Group Ltd. All rights rese
Slide 29: Medtech target sales achieved; M&A Effects
FY2024 Topic [Medtech] Target sales of 5 billion yen achieved (Billion yen) 51.69 28.40 24.27 17.95 2021 2022 2023 2024 M&A Effects © 2025 GNI Group Ltd. All rights reserved Reference Translation 28
Slide 30: Partnership with JAIC
FY2024 Topic [GNI] Partnership with JAIC Holding 18.7% of JAIC's shares 1. Attract capital from global investors including China, the US and Europe to Japanese companies 2. Support the expansion of products held by invested companies into the Chinese market 3. Explore the possibility of forming grou
Slide 31: Selected for JPX-Nikkei Mid and Small Cap Index
FY2024 Topic [GNI] Selected for JPX-Nikkei Mid and Small Cap Index • Effective from August 30 • 1.86% →2.11％* of the portfolio • GNI Group has a high free-float market capitalization and holds the second highest weighting among the 200 stocks Goals for this FY and beyond: JPX-Nikkei Index 400 Index
Slide 32: Performance Comparison of Our Stock and Index
[Reference] Performance Comparison of Our Stock and Index Index / Stock Price Annual Change Rate（2023-2024） 東証グロース指数 TOPIX 17.9％ TSE Growth Market (8.6)％ GNI Group (2160) 20.3％ TSE Growth Market • The longest consecutive decline in history for four years • TSE Growth Market was sold off amid rising
Slide 33: 4. Financial Forecasts for FY2025
4. Financial Forecasts for FY2025 © 2025 GNI Group Ltd. All rights reserved Reference Translation 32
Slide 34: Financial Forecasts for FY2025
Financial Forecasts for FY2025 Consolidated Financial Results Does not include Cullgen's milestone revenues and M&A revenues FY2024 FY2025 Inc./ (Dec.) Millions of yen Actual Forecast Revenue 23,611 28,733 21.7% Gross profit 18,037 22,954 27.3% Operating profit 1,391 23,217 1569.1% Income before inc
Slide 35: 5. FY2025 Topics
5. FY2025 Topics © 2025 GNI Group Ltd. All rights reserved Reference Translation 34
Slide 36: Seek new licensing alliances for the future
FY2025 Topic [Biotech] Seek new licensing alliances for the future Target Drug Lead PCC IND 第１相臨床試 Target Indication Selection discovery Optimization Selection enabling PhaseⅠ 験 Events Enrollment to dose level 4 is TRK Solid tumors anticipated to complete in Q1 2025 Acute and chronic Phase 1 clinica
Slide 37: Cullgen's listing
FY2025 Topic [Biotech] Cullgen's listing Pending approval by CSRC *It was listed one week after the CSRC application was accepted when GYRE was listed Listing promptly after approval Assumed gain on GNI ownership on listing (operating profit) At the time of announcement (November 13, 2024): 14.8 bil
Slide 38: Further expansion of Medtech business
FY2025 Topic [Medtech] Further expansion of Medtech business 1. Expansion of sales lineup through new product launches 2. New sales in China and US Aiming for sales scale of 10 billion yen in 3 years © 2025 GNI Group Ltd. All rights reserved Reference Translation 37
Slide 39: To establish domestic business
FY2025 Topic [GNI] To establish domestic business Accelerate business growth including investment and M&A Obtaining cash flow Establish a management base that is not dependent on group companies © 2025 GNI Group Ltd. All rights reserved Reference Translation 38
Slide 40: 6. GNI Group's Value Proposition
6. GNI Group’s Value Proposition © 2025 GNI Group Ltd. All rights reserved Reference Translation 39
Slide 41: GNI Group's Value Proposition: Stable revenue base
GNI Group’s Value Proposition Stable revenue base Sales products and sales systems that lead to reliable sales ＋ Development capabilities to support future growth R&D technologies and systems that lead to future profits Become a global mid-sized pharmaceutical company capable of high profitability a
Slide 42: Highly profitable vertical integration model
Highly profitable vertical integration model • Developed a unique model by integrating all stages from API production to sales within the group • The average gross margin over the past five years : 95.3% API manufacturing Minimize risk of shortage in procurement of API Formulation Minimize the OEM r
Slide 43: Market capitalization 167.8 billion yen
GNI Group’s Value Proposition Market capitalization 167.8 billion yen ≠Resolution of valuation gap Pharma/Biotech Biotech Medtech Listed on NASDAQ in 2023 Announced listing on NASDAQ in 2024 Prepare for the future listing Market capitalization of GNI Market capitalization of GNI Market capitalizatio
Slide 44: 7. Supplementary Materials
7. Supplementary Materials © 2025 GNI Group Ltd. All rights reserved Reference Translation 43
Slide 45: Reinforcement of future revenue base
[Pharmatech] Reinforcement of future revenue base Product Indication Progress Events of 2025 Phase 2 clinical trial expected to be F573 ALF/ACLF Phase 2 completed by December 2026 Choronic Obstructive The IND submission is scheduled in F528 Preclinical Pulmonary(COPD) December 2025 Pulmonary Arteria
Slide 46: F351 Phase 3 Clinical Trial Results Received
[Pharmatech] F351 Phase 3 Clinical Trial Results Received Schedule to the market Events Date Completion of Phase 3 clinical trials October 2024 Topline data disclosure Awaiting the release of the analysis results NDA application 2 to 3 months after data release if smooth NDA approval 6 to 8 months
Slide 47: Comparison of ETUARY and F351
[Pharmatech] [Reference] Comparison of ETUARY® and F351 ETUARY® F351 Approx. 100 million people（2021） Number of patients Approx. 0.12 million（2021） Hepatitis B+MASH Yearly cost per person 2 million yen ？？？ Revenue 15.6 billion yen（2024） ？？？ Trends in the Number of Pulmonary Fibrosis Patients in Chin
Slide 48: Group structure
Group structure GNI Group Ltd. Tokyo, Japan (TSE: 2160) 100％ 74％ 100％ GNI GNI 26％ Shanghai USA Hong Kong Genomics 60％ 100％ 20％ 85％ 40％ 65％ 80％ Miclene Berkeley Advanced Gyre Therapeutics Shanghai Shanghai Healthcare OsDerma Cullgen Genomics Biomaterials (NASDAQ: GYRE) REEF Technology DMAH Biomateria
Slide 49: Development Pipeline of Gyre Therapeutics & Gyre Pharmaceuticals
Development Pipeline of Gyre Therapeutics & Gyre Pharmaceuticals Candidate Indication Location Preclinical Phase 1 Phase 2 Phase 3 NDA Marketed MASH-Associated Plan to initiate Phase 2a trial in 2025 USA F351 Liver Fibrosis (Hydronidone) CHB-Associated Liver Completed Phase 3 trial Fibrosis in Octob
Slide 50: Development pipeline of Cullgen
Development pipeline of Cullgen Hit Target Drug Lead PCC IND Target Indication Selection discovery Optimization Selection enabling PhaseⅠ 第１相臨床試験 TRK Solid tumors TRK Acute and chronic pain Leukemia and GSPT1 MYC + cancers Epigenetic Prostate, lung & Factor bladder cancers Clinical trial initiated N
Slide 51: Market Capitalization Trends of Peer Companies and GYRE
"What Does the Future Hold for GYRE Based on The Market Capitalization Trends of Peer Companies?” Company A Date Stock price Market cap Dec. 18, 2022 （Announced positive results Market Cap as of October 18, 2024 63.8 USD 200 billion yen from the phase 3 clinical 197 billion JPY trial） Dec. 19, 2022
Slide 52: Contact Info: GNI Group Ltd. Investor Relations
Contact Info: GNI Group Ltd. Investor Relations : IR@gnipharma.com : www.gnipharma.com This presentation contains statements concerning the current plans, expectations and strategies of GNI Group Ltd. (GNI Group). Any statements contained herein that pertain to future operating performance and that