Slide 1: GNI Group Ltd. Financial Results for Q3 FY2025
GNI Group Ltd. Financial Results for Q3 FY2025 Securities Code: 2160
Slide 2: We Bring New Hope to Life
We Bring New Hope to Life © 2025 GNI Group Ltd. All rights reserved 1
Slide 3: Agenda
Agenda 1. Company Overview 2. Q3 FY2025 Segment Results 3. Q3 FY2025 Financial Highlights 4. Financial Forecast for FY2025 © 2025 GNI Group Ltd. All rights reserved 2
Slide 4: 1. Company Overview
1. Company Overview © 2025 GNI Group Ltd. All rights reserved 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. To develop new treatments for unmet medical needs, He is leveraging the unique strengths of the pharmaceutical industries in Japan, the U.S., and the PRC, and pioneering a new, highly profitable business model. He obtained
Slide 7: Major Pharmaceutical & Drug Discovery (Candidate)
Major Pharmaceutical & Drug Discovery (Candidate) [Pharma] ETUARY® (Generic name：Pirfenidone) Chinese：艾思瑞® • Treatment for idiopathic pulmonary fibrosis (IPF) • The Group’s flagship product Contiva® (Generic Name: Avatrombopag Maleate Hydrochloride) Chinese Name: 康曲欣® • Launched in March 2025 • A li
Slide 8: Making the leap to a global pharmaceutical company through subsidiary listing strategy
Making the leap to a global pharmaceutical company through subsidiary listing strategy Promoting the establishment to recruit high talents for a global management structure to achieve sustainable growth and maximize shareholder value, while mitigating key-person risk centered on the CEO Pharma Biote
Slide 9: Main Group Structure
Main Group Structure GNI Group Ltd. (TSE: 2160) Pharma / Drug discovery Medical Devices Other Drug discovery (Biomaterials) 80％ 40％ 100％ 100％ Gyre Therapeutics Cullgen Berkeley Advanced Shanghai (NASDAQ: GYRE) Biomaterials Genomics Drug Discovery Drug Discovery Biomaterials Manufacturing / Sales for
Slide 10: 2. Q3 FY2025 Segment Results
2. Q3 FY2025 Segment Results © 2025 GNI Group Ltd. All rights reserved 9
Slide 11: Pharma
Pharma Financial Results 2024（Quarterly） FY2025（Quarterly） Q3（Cumulative） FY2021 FY2022 FY2023 FY2024 FY2025 Actual Actual Actual Actual Inc. / Forecast Q1 Q2 Q3 Q1 Q2 Q3 2024 2025 Millions of yen (Dec.) Revenue 9,868 13,346 15,742 15,847 3,982 3,862 3,778 3,315 3,856 4,488 11,622 11,659 0.3% 20,202
Slide 12: Etuary sales showed strong growth, recording the highest-ever monthly sales
[Pharma] Etuary® Etuary® sales showed strong growth, recording the highest-ever monthly sales Since its launch in 2014, sales in September reached an all-time high. On a quarterly basis, sales in FY2024 Q3 were the third highest since 2023, when there was a temporary surge in demand, maintaining a s
Slide 13: Inclusion of Etorel in Volume-Based Procurement Program
Inclusion of Etorel® in Volume-Based Procurement Program Overview of the VBP System The VBP system is a government-led centralized procurement scheme in the PRC aimed at lowering drug prices and reducing patients’ medical burden through large-scale purchases and competitive bidding. Not only generic
Slide 14: [Pharma] Progress of Main Products
[Pharma] Progress of Main Products While the short-term impact of policy factors on generic drug sales revenue remains uncertain, the development of new drugs and the expansion of existing product indications key pillars of medium to long-term growth are steadily advancing. Pirfenidone (Etuary®) F35
Slide 15: Hepatitis is the second most common cause of death from infectious disease
F351: Bring New Hope to Life, Powering a Brighter Future for CHB Patients. Hepatitis is the second most common cause of death from infectious disease in the world World Hepatitis Summit 9 April 2024 WHO: Global hepatitis report 2024 Estimated deaths from viral hepatitis will increase from • People i
Slide 16: An estimated 60-79.7 million people in China are infected with hepatitis B virus
F351: Bring New Hope to Life, Powering a Brighter Future for CHB Patients. An estimated 60-79.7 million people in China are infected with hepatitis B virus Stage Description Infection with the hepatitis B virus. If the acute hepatitis does not resolve and becomes chronic, it is referred 1. HBV Infec
Slide 17: Estimated Peak Patient Population for F351
F351: Bring New Hope to Life, Updated on 14 August 2025 Powering a Brighter Future for CHB Patients. Estimated Peak Patient Population for F351: approximately 3.0 to 7.5 million# (based on GNI’s own view) 1. Number of Hepatitis B Patients Terms Number of people proportion Survey results: published i
Slide 18: GNI Group Growth Vision through In-House Pipeline
GNI Group Growth Vision through In-House Pipeline Sustainable Growth Through the Development of Multiple Blockbuster Candidates (based on GNI’s own view) Drug Value F351 Launch Grobal Expansion Based on Launch of Next-Generation Cullgen Blockbuster Candidate, F528 • Targeting the Chinese Market • De
Slide 19: [Pharma] Development Pipeline
[Pharma] Development Pipeline (based on GNI’s own view) Product Indication Location Preclinical Phase 1 Phase 2 Phase 3 NDA Marketed Development Progress Chronic Obstructive Pulmonary Plan to submit an IND application F528 Disease (COPD) - in 2026 Plan to submit an IND application Advanced Liver Fib
Slide 20: Biotech
Biotech FY2024（Quarterly） FY2025（Quarterly） Q3（Cumulative） FY2021 FY2022 FY2023 FY2024 FY2025 Actual Actual Actual Actual Inc. / Forecast Q1 Q2 Q3 Q1 Q2 Q3 2024 2025 Millions of yen (Dec.) Revenue 0 0 5,805 1,439 401 353 332 353 127 273 1,086 753 (30.7)% 955 Operating profit (1,920) (2,794) 2,374 (3
Slide 21: [Biotech] Reverse Merger Transaction
[Biotech] Reverse Merger Transaction The listing procedures for the Nasdaq market are currently awaiting approval# • One of the listing conditions, the approval of the proposal at Pulmatrix’s shareholders’ meeting, was secured on June 16, 2025, completing the reverse merger transaction. • The remain
Slide 22: Medtech
Medtech FY2024（Quarterly） FY2025（Quarterly） Q3（Cumulative） FY2021 FY2022 FY2023 FY2024 FY2025 Actual Actual Actual Actual Inc. / Forecast Q1 Q2 Q3 Q1 Q2 Q3 2024 2025 Millions of yen (Dec.) Revenue 1,795 2,428 2,841 5,189 1,290 1,220 961 1,370 2,621 2,083 3,471 6,075 75.0% 6,159 Operating profit 844
Slide 23: Medtech
Medtech Following Q2, cumulative results reached a new record high • Cumulative Q3 sales achieved 96.8% of the budget, and full-year sales are expected to exceed the budget. • Due to the November 2023 acquisition of the Orthobiologics business and the establishment of BB the operating margin has tem
Slide 24: The Medtech Group's First Proprietary Brand Strategic Product
The Medtech Group’s First Proprietary Brand Strategic Product Sales of private-brand (PB) products based on the Group’s aim to establish an in-house manufacturing and sales framework • The strategic products that BAB plans to sell are highly biocompatible and effective for various types of damage, i
Slide 25: U.S. Medicare System Reform and Its Impact
U.S. Medicare System Reform and Its Impact What is the Medicare System? Status and Details of the System Reform A public health insurance program in the U.S. covering more than 60 • On October 31, 2025, the U.S. government announced million elderly and certain disabled individuals under specific con
Slide 26: [Medtech] Expansion into OsDerma and Medical Aesthetics Market
[Medtech] Expansion into OsDerma and Medical Aesthetics Market GNI Group's Business Platform Synergies to be Realized Expand market share in the high-end cosmetic Competitive advantage over peers medicine market and establish a brand Tighter regulations on off-label use in the cosmetic surgery field
Slide 27: Other Segment
Other Segment Pharma Biotech Medtech Others Millions of yen Q3 2024 Q3 2025 Q3 2024 Q3 2025 Q3 2024 Q3 2025 Q3 2024 Q3 2025 Revenue 11,622 11,659 1,086 753 3,471 6,075 1,018 889 Operating profit 3,495 3,123 (2,189) (3,443) 859 1,439 2,827 (2,223) Details of the “Other” Segment (for information on th
Slide 28: 3. Q3 FY2025 Financial Highlights
3. Q3 FY2025 Financial Highlights © 2025 GNI Group Ltd. All rights reserved 27
Slide 29: Consolidated Income Statement
Consolidated Income Statement Existing businesses delivered stable revenue, returning to profitability in Q3, with cumulative losses narrowing. Millions of yen Q3 2024 Q3 2025 Inc. / (Dec.) Factors for increase/decrease • Existing Pharma and MedTech businesses drove revenue Revenue 17,192 19,357 2,1
Slide 30: Consolidated Balance Sheet
Consolidated Balance Sheet Significant increase in cash and cash equivalents as well as capital stock due to the public offering Millions of yen Q4 FY2023 Q4 FY2024 Q3 FY2025 Inc. / (Dec.) Total non-current Assets 33,475 42,720 41,442 (1,278) Goodwill 14,246 15,994 15,071 (923) Intangible assets 8,8
Slide 31: Consolidated Balance Sheet/ Goodwill and Intangible Assets
Consolidated Balance Sheet/ Goodwill and Intangible Assets Millions of yen Major Breakdown Q4 FY2023 Q4 FY2024 Q3 FY2025 Inc. / (Dec.) Variance Factors All changes in goodwill are due to exchange rate 14,246 15,995 15,071 (924) fluctuations. Gyre Pharmaceuticals 173 188 181 (7) Gyre Therapeutics 7,0
Slide 32: Cash Flow
Cash Flow Q3 FY2024 Q3 FY2025 Note Millions of yen • Although the pre-tax loss of JPY 1.08 billion had a significant impact, the deficit in cash flow narrowed Cash Flow from Operating Activities (2,057) (707) due to factors such as a reduction in corporate tax expenses. • Increase in expenditures ma
Slide 33: R&D expense
R&D expense • Increase in R&D expenses related to Cullgen’s development progress (up JPY 508 million YoY) • The capitalization of F351’s Phase 3 clinical trial has been accounted for in accordance with accounting standards and tax regulations in the PRC. • Capitalized development costs increased due
Slide 34: Forex sensitivity
Forex sensitivity Exchange rate FY 2025 FY2023 Actual FY2024 Actual Forecast Q3 Actual USD/JPY 140.67 151.69 145.00 148.08 CNY/JPY 19.82 21.04 20.50 20.50 Forex sensitivity Foreign exchange fluctuations affect yen-converted figures, with only a limited impact on profit margins. Revenue Operating pro
Slide 35: 4. Financial Forecasts for FY2025
4. Financial Forecasts for FY2025 © 2025 GNI Group Ltd. All rights reserved 34
Slide 36: Financial Forecasts for FY2025
Financial Forecasts for FY2025 Consolidated Results No change in the forecast Millions of yen FY2024 Actual FY2025 Forecast Revenue 23,611 28,733 Gross profit 18,037 22,954 Operating profit 1,402 23,217 Income before income taxes 238 22,541 Net profit (9) 15,868 Profit attributable to owners of the
Slide 37: 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