Gni Group Ltd. · TSE:2160
Gni — Q2 2026 Earnings Presentation
51 slides from Gni's earnings presentation, Aug 18, 2026
Slide 1: Q2 FY2026 Financial Results Presentation
GNI Group Ltd. Q2 FY2026 Financial Results Presentation We Bring New Hope to Life August 18, 2026 Securities Code: TSE:2160
Slide 2: Agenda
We Bring New Hope to Life Agenda 1. Toward a Second Founding Phase 1.1 Strategic Rational for the Acquisition 1.2 Group Synergies (Pain) 1.3 Group Synergies (Rheumatism) 1.4 Group Synergies (GNI Group BD Dept.) 2. Q2 FY2026 Financial Highlights 3. Q2 FY2026 Segment Results 4. Appendix 4.1 AYUMI Phar
Slide 3: 1.1 Toward a Second Founding Phase: Strategic Rationale for the Acquisition
We Bring New Hope to Life 1.1 Toward a Second Founding Phase: Strategic Rational for the Acquisition © 2026 GNI Group Ltd. All rights reserved 3
Slide 4: Strategic Significance of the Acquisition: Building a Profitable Foundation for the Japan Business
We Bring New Hope to Life Pre-Acquisition Challenges: Strategic Significance of the Acquisition: Building a Profitable Foundation for the Japan Business Aiming to Become a Global BioPharma, with Japan Business Profitability as the Next Growth Driver [Current Situation] Profit by Region Continued los
Slide 5: AYUMI Pharmaceutical: Strategic Rationale and Transaction Validity
We Bring New Hope to Life AYUMI Pharmaceutical: Strategic Rationale and Transaction Validity An acquisition combining a strong domestic business platform with clear strategic and financial rationale to accelerate growth across the Group 1. Strategic Rationale for the Acquisition of 2. Rationale for
Slide 6: Completing the Global Platform with Japan as the Final Piece
We Bring New Hope to Life Completing the Global Platform with Japan as the Final Piece Linking the Group’s U.S., China, and Japan Operations GNI Group Headquarters / TSE-Listed Entity (TSE:2160) Building a Globally Integrated Innovation Platform through Closer Collaboration Active Collaboratio
Slide 7: Launchpad for an Emerging Global Biopharma
We Bring New Hope to Life Launchpad for an Emerging Global Biopharma Acquired ZooLabo, Merged GYRE and Cullgen, Acquired Ayumi, Rebuilding Medtech GNI Group Group Company (2160.T) Gyre Therapeutics Ayumi Pharmaceuticals Medtech Group Global drug discovery and development Anchor for Japanese Health
Slide 8: Pipeline
We Bring New Hope to Life Pipeline *The development details and schedule may change depending on future progress and other factors. In addition, the Ayumi Pharmaceutical product pipeline shown in the table below presents selected major products and does not cover all products. Location Product Modal
Slide 9: Growth Trend Built around Three Core Businesses
We Bring New Hope to Life Growth Trend Built around Three Core Businesses Building a Foundation across Pharma, Biotech, and Medtech toward Becoming a Global Biopharma Assuming Full-Year Consolidation of AYUMI Pharmaceutical Revenue Operating Profit/ Loss (Millions of yen) 68,482 Consolidated from Q3
Slide 10: 1.2 Group Synergies (Pain)
We Bring New Hope to Life 1.2 Toward a Second Founding Phase: Group Synergies (Pain) © 2026 GNI Group Ltd. All rights reserved 10
Slide 11: Pain: Overview of CALONAL
We Bring New Hope to Life Pain: Overview of CALONAL CALONAL is AYUMI Pharmaceutical’s proprietary brand Sustained strong sales growth supported by distinctive product characteristics, strong competitive advantages, inclusion in treatment guidelines, and expanded indications FY ended March 2026 Sales
Slide 12: Group Synergies in the Pain Management Field
We Bring New Hope to Life Group Synergies in the Pain Management Field CG001419, a non-opioid, non-NSAID pain treatment candidate being developed by our Group, is expected to contribute to strengthening Ayumi Pharmaceutical’s product portfolio in the pain management field over the medium to long ter
Slide 13: The Role for TRKA in Nociception and Analgesia Has Been Validated in Humans
We Bring New Hope to Life The Role for TRKA in Nociception and Analgesia Has Been Validated in Humans A. Nerve growth factor (NGF) stimulates the TrkA signaling pathway to transmit pain to the central nervous system TrkA NGF Injury / Inflammation NGF-TRKA complex Dorsal root ganglion (DRG) Brain B.
Slide 14: Summary of Phase 1 PD, PK and Safety Study of CG001419
We Bring New Hope to Life Summary of Phase 1 PD, PK and Safety Study of CG001419 Well tolerated at all dose levels, with no drug-related serious adverse events reported (announced on December 15, 2025) CG001419-101 (NCT06636500): a SAD/MAD/FE study in healthy subjects in Australia • The surrogate PD
Slide 15: 1.3 Group Synergies (Rheumatism)
We Bring New Hope to Life 1.3 Toward a Second Founding Phase: Group Synergies (Rheumatism) © 2026 GNI Group Ltd. All rights reserved 15
Slide 16: Strengths in Rheumatology
We Bring New Hope to Life Strengths in Rheumatology AYUMI Pharmaceutical has established strong sales capabilities across a broad network of hospitals and clinics through its extensive portfolio of antirheumatic drugs and comprehensive information support AYUMI’s Broad Portfolio Covering a Wide Rang
Slide 17: Dual Targeting of TYK2 and JAK1 for Autoimmune Diseases
We Bring New Hope to Life Dual Targeting of TYK2 and JAK1 for Autoimmune Diseases, Focus on Systemic Lupus Erythematosus and Rheumatoid Arthritis A. TYK2/JAK - STAT signaling B. SLE Mechanism C. RA Mechanism Tsokos GC.(2011) NEJM PMID: 22129255 McInnes & Schett (2011) NEJM PMID: 22150039 • 125,000,0
Slide 18: CG620953 Demonstrates Superior Efficacy in Preclinical Models of Lupus and RA
We Bring New Hope to Life CG620953 Demonstrates Superior Efficacy in Preclinical Models of Lupus and Rheumatoid Arthritis (RA) A. CG620953 is effective in a mouse model of systemic lupus erythematosus (SLE) Dorsal skin lesion score Kidney injury histopathology score Survival rate Kidney histopatholo
Slide 19: 1.4 Group Synergies (GNI Group BD Dept.)
We Bring New Hope to Life 1.4 Toward a Second Founding Phase: Group Synergies (GNI Group BD Dept.) © 2026 GNI Group Ltd. All rights reserved 19
Slide 20: GNI Group: Business Development Headquarters
We Bring New Hope to Life GNI Group: Business Development Headquarters GNI Group will take the lead in creating synergies through alliances across the Group Establishing a Strong Medical and Pharmaceutical Platform in Japan Industry Network Build relationships with leading medical institutions and p
Slide 21: 2. Q2 FY2026 Financial Highlights
We Bring New Hope to Life 2. Q2 FY2026 Financial Highlights © 2026 GNI Group Ltd. All rights reserved 21
Slide 22: Q2 FY2026 Financial Highlights
We Bring New Hope to Life Q2 FY2026 Financial Highlights JPY 500M Operating Profit Despite One-Time M&A and Restructuring Costs Foundation Set for Accelerated Growth from FY2027 • Operating profit was supported in part by a gain on reversal of accrued interest related to the integration, while acqui
Slide 23: Consolidated Income Statement (Q2 YTD: January–June)
We Bring New Hope to Life Consolidated Income Statement (Q2 YTD: January–June) Despite the recognition of certain acquisition-related expenses for AYUMI Pharmaceutical in SG&A expenses, operating profit turned positive, supported by a gain on reversal of accrued interest related to Cullgen’s preferr
Slide 24: Consolidated Balance Sheet
We Bring New Hope to Life Consolidated Balance Sheet • Liabilities decreased significantly following Gyre’s acquisition of Cullgen as a wholly owned subsidiary; changes in ownership interests resulting from intra-group reorganization altered the Group’s capital structure. • The capital structure is
Slide 25: Consolidated Balance Sheet / Goodwill and Intangible Assets
We Bring New Hope to Life Consolidated Balance Sheet / Goodwill and Intangible Assets An impairment loss of JPY 667 million was recognized following a review of future plans in anticipation of the restructuring of the Medtech business. The increase was mainly driven by higher capitalized development
Slide 26: R&D expense
We Bring New Hope to Life R&D expense • R&D expenses increased YoY due to progress in development preparations for the U.S. expansion of F351 at Gyre. • The increase in capitalized development expenses was mainly attributable to Gyre Pharmaceuticals, reflecting NDA- related expenses for the commerci
Slide 27: FY2026 Consolidated Earnings Forecast
We Bring New Hope to Life FY2026 Consolidated Earnings Forecast Consolidated Results: Revenue from AYUMI Pharmaceutical for the second half of FY2026 to be reflected in the Pharmaceutical segment FY2026 Previous Forecast FY2026 Revised Forecast FY2024 Actual FY2025 Actual Announced Mar. 31, 2026 Ann
Slide 28: 3. Q2 FY2026 Segment Results
We Bring New Hope to Life 3. Q2 FY2026 Segment Results © 2026 GNI Group Ltd. All rights reserved 28
Slide 29: Pharma
We Bring New Hope to Life Pharma Financial Results FY2021 FY2022 FY2023 FY2024 FY2025 FY2025(Quarterly) FY2026(Quarterly) FY2026 Inc. /(Dec) (Millions of Yen) Actual Actual Actual Actual Actual Q2 Q2 Forecast Revenue 9,868 13,346 15,742 15,847 17,314 7,171 8,202 1,031 *40,622 Operationg Profit 2,501
Slide 30: Process Toward F351 Launch
We Bring New Hope to Life Process Toward F351 Launch Received formal acceptance notification for the New Drug Application (NDA) on May 13, 2026. Currently under review with Priority Review designation. Description Progress 1. Pre-NDA Meeting Prior consultation with the regulatory authority before ND
Slide 31: Biotech
We Bring New Hope to Life Biotech Financial Results FY2025 FY2026 FY2021 FY2022 FY2023 FY2024 FY2025 (Quarterly) (Quarterly) FY2026 Inc. /(Dec) Actual Actual Actual Actual Actual Forecast (Millions of Yen) Q2 Q2 Revenue 0 0 5,805 1,439 789 480 177 (303) *177 Operating Profit (1,920) (2,794) 2,374 (3
Slide 32: Major Pharmaceutical & Drug Discovery of Gyre (Candidate)
We Bring New Hope to Life Major Pharmaceutical & Drug Discovery of Gyre (Candidate) Pharmaceutical products Drug Discovery ETUARYTM F351 (Generic name:Pirfenidone) Chinese: 艾思瑞® (Generic name:Hydronidone) • Treatment for idiopathic pulmonary fibrosis (IPF) • A potential blockbuster drug candidate fo
Slide 33: Major Drug Discovery of Cullgen (Candidate)
We Bring New Hope to Life Major Drug Discovery of Cullgen (Candidate) Aiming to create new drugs by leveraging its proprietary TPD platform, uSMITE Drug Discovery CG001419 (Acute and chronic pain) CG009301 (Leukemia, MYC) • Potential to become a first-in-class oral pan-TRK protein degrader for pain
Slide 34: Medtech
We Bring New Hope to Life Medtech Financial Results FY2025 FY2026 FY2021 FY2022 FY2023 FY2024 FY2025 (Quartery) (Quartery) FY2026 Inc. /(Dec) Actual Actual Actual Actual Actual Forecast (Millions of Yen) Q2 Q2 Revenue 1,795 2,428 2,841 5,189 7,584 3,991 2,928 (1,063) *5,647 Operationg Profit 844 1,1
Slide 35: Medtech: Company-Wide Resource Optimization for the Second Founding Phase
We Bring New Hope to Life Medtech: Company-Wide Resource Optimization for the Second Founding Phase — Strategic Shift from “Quantity to Quality” With the consolidation of AYUMI Pharmaceutical, The Medtech business will move away from its Medtech’s share of Group revenue will effectively previous str
Slide 36: The Medtech Group's First Proprietary Brand Strategic Product
We Bring New Hope to Life 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
Slide 37: Expansion into the Medical Aesthetics Market through OsDerma
We Bring New Hope to Life 【Medtech】Expansion into the Medical Aesthetics Market through OsDerma DermiraCa® Developed by OsDerma Aiming to Expand Market Share and Establish a Strong Competitive Advantages Brand in the Premium Medical Aesthetics Market Tighter Regulation of Off-Label Use in Medical Ae
Slide 38: Other Segment
We Bring New Hope to Life Other Segment The Other segment consists of 14 companies, including GNI Group (the Company), which holds global headquarters functions, and Gyre Therapeutics, a Nasdaq-listed company that conducts research and development in the United States, as well as other entities maki
Slide 39: 4.1 Appendix: AYUMI Pharmaceutical Overview
We Bring New Hope to Life 4.1 Appendix: AYUMI Pharmaceutical Overview © 2026 GNI Group Ltd. All rights reserved 39
Slide 40: Business model
We Bring New Hope to Life Business model A specialty pharma that has built an efficient business model by focusing on select therapeutic areas Efficient investment in late-stage assets under strict criteria delivers outstanding stability and profitability Major originator companies Specialty pharma
Slide 41: FY2026 Consolidated Earnings Forecast – Ayumi Pharmaceutical
We Bring New Hope to Life FY2026 Consolidated Earnings Forecast – Ayumi Pharmaceutical Ayumi Pharmaceutical’s stable earnings base to contribute from H2 2026 (Q3 onward) Ayumi Pharmaceutical – 3-Year Financial Performance* Growth Strategy (百万円) Revenue Operating Profit Operating Margine Profitabilit
Slide 42: 4.2 Appendix: F351
We Bring New Hope to Life 4.2 Appendix: F351 © 2026 GNI Group Ltd. All rights reserved 42
Slide 43: F351: Bring New Hope to Life, Powering a Brighter Future for CHB Patients
We Bring New Hope to Life 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 (p244) Estimated deaths from viral hepati
Slide 44: An estimated 60-79.7 million people in China are infected with hepatitis B virus
We Bring New Hope to Life 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,
Slide 45: Estimated Peak Patient Population for F351: approximately 3.0 to 7.5 million
We Bring New Hope to Life 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 S
Slide 46: Estimated total number of patients treated by the top three products
We Bring New Hope to Life Estimated total number of patients treated by the “top three” products Recommended in China’s National Estimated Retail Product Name Key Manufacturer Estimated Wholesale Value Market Share Market Positioning & Share Status Clinical Guidelines / Annual Cost Raw Materials Val
Slide 47: Estimated total number of patients treated by the top three products
We Bring New Hope to Life Estimated total number of patients treated by the “top three” products Based on market data, it is estimated that approximately 0.4–0.6 million patients in China are effectively receiving treatment annually with three major traditional Chinese medicines. Given an estimated
Slide 48: F351 is expected to drive demand and establish a new market
We Bring New Hope to Life F351 is expected to drive demand and establish a new market Historically, in Western medicine, the treatment of chronic hepatitis B Traditional Chinese medicines primarily contribute through anti-fibrotic effects and immune modulation. has been limited to "delaying" disease
Slide 49: Number of Patients on Antiviral Therapy for Hepatitis B in China
We Bring New Hope to Life Number of Patients on Antiviral Therapy for Hepatitis B in China According to studies by the China Center for Disease Control and Prevention (CDC) and the WHO-affiliated Polaris Observatory, it is estimated that approximately 5–6 million patients in China are receiving anti
Slide 50: Main Group Structure
We Bring New Hope to Life Main Group Structure GNI Group Ltd. TSE:2160 Pharma/ Drug discovery Medical Devices Other (Biomaterials) 100% 100% 70% 100% Berkeley Advanced Shanghai Genomics Gyre Therapeutics Biomaterials (Nasdaq: GYRE) Ayumi Pharmaceutical Holdings Biomaterials Manufacturing / Sales for
Slide 51: Contact Info: GNI Group Ltd. Investor Relations
We Bring New Hope to Life 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 opera