Slide 1: FY2022 Q4 Year to Date Financial Results Corporate Presentation
GNI Group Ltd. FY2022 Q4 Year to Date Financial Results Corporate Presentation February 17, 2023 We Bring New Hope to Patients. Ying Luo (罗楹),PhD President and Chief Executive Officer Joseph Francis Meyer (マイヤー) Chief Financial Officer Securities Code: 2160
Slide 2: Forward-looking Statements
We Bring New Hope to Patients Forward-looking Statements 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 are not historic facts are for
Slide 3: Contents
We Bring New Hope to Patients Contents 1 FY2022 & Q4 Executive Summary 2 Financials 3 Pharmaceutical Pillar 4 Biomaterials / Medical Device Pillar 5 Appendix © 2023 GNI Group Ltd. All rights reserved 3
Slide 4: Competitive Edge: A Profitable Drug Discovery Platform
We Bring New Hope to Patients 1. Executive Summary Competitive Edge: A Profitable Drug Discovery Platform ✓ Revolutionary TPD (Targeted ✓ Steady income stream from BC and Protein Degradation) drug Sustainable BAB; Revenue up 35% and 31% YoY Cutting-edge discovery platform Profitability to in yen ter
Slide 5: Cost-Efficient Platform
We Bring New Hope to Patients 1. Executive Summary Cost-Efficient Platform China Presence leverages Group as a whole US, Japan, China China Global Clinical Development, Global Clinical Basic Proof-of-Concept, Development and Research Fast-to-Market, Profit Commercialization ▪ Efficiency ▪ Global tal
Slide 6: Strengthening our Foundation
We Bring New Hope to Patients 1. Executive Summary Strengthening our Foundation Corporate Reach and Expansion • Completed 1st stage of acquisition of Nasdaq-listed CBIO1) to increase US operation Business Development and Strategic Positioning • JV established in China for deployment of BAB’s2) bioma
Slide 7: Corporate Citizenship
We Bring New Hope to Patients 1. Corporate 1. Executive Profile Summary Corporate Citizenship Environment Social Governance • BC holds GB/T24001:2016* • BC’s donation of ETUARY to NPO in • 7 directors and managers in total Certificate China up 26.6% YoY enrolled in BDTI’s*** director training • BC k
Slide 8: Contents
We Bring New Hope to Patients Contents 1 FY2022 & Q4 Executive Summary 2 Financials 3 Pharmaceutical Pillar 4 Biomaterials / Medical Device Pillar 5 Appendix © 2023 GNI Group Ltd. All rights reserved 8
Slide 9: GNI Group: A decade of Growth
We Bring New Hope to Patients 2. FY2022 Financials GNI Group: A decade of Growth Revenue CAGR: 66% (Million JPY) Operating income CAGR: 55% 18,000 13,000 8,000 3,000 -2,000 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 Revenue 183 475 1,017 1,307 2,648 5,019 7,446 9,774 12,690 17,419 Operating i
Slide 10: Q4 Macro Environment and Backdrop
We Bring New Hope to Patients 2. FY2022 Financials Q4 Macro Environment and Backdrop • High inflation pressures and dramatic FX swings • Operations normalizing with COVID restrictions easing worldwide in Q4 • Supply chain pressures Open questions for 2022-23: • Will firehose of capital into early st
Slide 11: CBIO Transaction Highlights
We Bring New Hope to Patients 2. FY2022 Financials CBIO Transaction Highlights • Unlock IP value ($35 million) for the F351 After Program with a view to NASH unmet needs in Special Dividend US • No dilution to GNI’s holding in China business operation with more than 80% holdings in CBIO • Medium ter
Slide 12: Strong Operating Growth, Challenging Environment
We Bring New Hope to Patients 2. FY2022 Financials Strong Operating Growth, Challenging Environment Group Consolidated P/L Million JPY Revenue: Up 37% YoY FY2020 FY2021 FY2022 20 vs 21 21 vs 22 Revenue 9,774 12,690 17,419 30% 37% SG&A: BC’s one-time IPO expenses JPY 395M COGS (1,546) (1,600) (2,674)
Slide 13: In-depth Analysis: Adjusted View of PnL for One-off and Non-cash Items
We Bring New Hope to Patients In-depth Analysis: Adjusted View of PnL for One-off and Non-cash Items ❑ The Group’s financial results from profitable operations of BC and BAB are offset by spendings in Cullgen R&D and headquarter administrative operations including income tax expenses. ❑ Adjusting th
Slide 14: Capital Allocation
We Bring New Hope to Patients 2. FY2022 Financials Capital Allocation Group Consolidated BS Million JPY FY21 vs. FY22 FY2020 FY2021 FY2022 20 vs 21 21 vs 22 Total assets +3,610 Current assets 13,025 18,187 17,147 40% -6% •+1,007 PPE: Acquisition of property, plant, and equipment in China •+1,027 Goo
Slide 15: Contents
We Bring New Hope to Patients Contents 1 FY2022 & Q4 Executive Summary 2 Financials 3 Pharmaceutical Pillar 4 Biomaterials / Medical Device Pillar 5 Appendix © 2023 GNI Group Ltd. All rights reserved 15
Slide 16: Powered by Growth in China Despite COVID Outbreak
We Bring New Hope to Patients 3. Pharmaceutical Powered by Growth in China Despite COVID Outbreak (Million JPY) Pharmaceutical Segment Growth 5 Year Segment Revenue Segment Profit 16,000 Revenue grew 38% YoY. Segment profit 14,000 is down due to increased R&D on TPD 12,000 platform. 10,000 8,000 Des
Slide 17: Next Breakthrough is Liver Fibrosis Therapy
We Bring New Hope to Patients 3. Pharmaceutical Next Breakthrough is Liver Fibrosis Therapy Prevalence of Liver Fibrosis in China Source: Fu-Sheng Wang, et al. The global burden of liver disease: the major impact of China. Hepatology. December 2014; Lin MH, et al. Liver Fibrosis in the Natural Cours
Slide 18: R&D: BC's Drug Pipeline in China
We Bring New Hope to Patients 3. Pharmaceutical R&D: BC’s Drug Pipeline in China Modest slowdown of F351 trial enrollees Q4’22 due to COVID-19 impact in China Beijing Continent pharmaceutical co. ltd Product Indicat ion Pre-clinical Phase I Phase II Phase III NDA Marketed Idiopathic Pulmonary Fibros
Slide 19: Beijing Continent Financials
We Bring New Hope to Patients 3. Pharmaceutical Beijing Continent Financials (Legal entity, local currency) 800,000 P/L 000s RMB 700,000 FY2020 FY2021 FY2022 20 vs 21 21 vs 22 600,000 Revenue 447,002 571,038 688,630 28% 21% 500,000 COGS 26,627 25,629 29,299 -4% 14% 400,000 Gross profit 420,375 545,4
Slide 20: Spotlight is on Targeted Protein Degrader (TPD)
We Bring New Hope to Patients 3. Pharmaceutical Spotlight is on Targeted Protein Degrader (TPD) Date Japan’s Media Title / One-line Summary Feb 14 Nikkei Biotechnology & Kyushu Univ. confirmed VGLL3’s efficacy as a target for fibrosis treatment Business drug, proceeding to explore applications to Ta
Slide 21: Targeted Protein Degrader (TPD) in focus
We Bring New Hope to Patients 3. Pharmaceutical Targeted Protein Degrader (TPD) in focus Overcoming limitations Demand for new of conventional drug Advancements in treatments for various discovery and technology diseases development Investment by key players Projected growing market Rising collabora
Slide 22: R&D: Cullgen's Drug Pipeline
We Bring New Hope to Patients 3. Pharmaceutical R&D: Cullgen’s Drug Pipeline Several promising new drug candidates for TPD are in progress. E3 ligase Expression & function E3A Broad & essential E3B Broad & essential Novel E3 Ligands E3E Tissue restrictive E3G Tumor enriched Target Disease indication
Slide 23: Contents
We Bring New Hope to Patients Contents 1 FY2022 & Q4 Executive Summary 2 Financials 3 Pharmaceutical 4 Biomaterials / Medical Device Pillar 5 Appendix © 2023 GNI Group Ltd. All rights reserved 23
Slide 24: Steady Growth and Cash Generation
We Bring New Hope to Patients 4. Biomaterials / Medical Device Steady Growth and Cash Generation (Million JPY) Medical Device Segment Growth 5 Year Segment Revenue Segment Profit Steadily growing and 3,000 generating cash 2,500 2,000 New product (bone fiber) under FDA registration 1,500 1,000 Expand
Slide 25: Berkeley Advanced Biomaterials Product Portfolio
We Bring New Hope to Patients 4. Biomaterials / Medical Device Berkeley Advanced Biomaterials Product Portfolio Advanced Bi-Ostetic H-Genin Allograft Mineralized Bi-Ostetic Cem-Ostetic BioActive Glass Graft (AMG) 100% DBM Machined Processed Cortical HA/TCP TCP+Bovine Calcium-based Products – Putty,
Slide 26: DMAH (Designated Marketing Authorization Holder) Services
We Bring New Hope to Patients 4. Biomaterials / Medical Device DMAH (Designated Marketing Authorization Holder) Services Support overseas clients through the life cycle of medical devices Pre approval Judgement of Post shipment marketing • Regulatory consulting • Judge whether • Post marketing safet
Slide 27: Biomaterials market opportunity
We Bring New Hope to Patients 4. Biomaterials / Medical Device Biomaterials market opportunity Advancements in technology Increasing demand for medical Rising demand for regenerative and materials science leading devices such as implants, wound medicine and tissue engineering to development of impro
Slide 28: Contents
We Bring New Hope to Patients Contents 1 FY2022 & Q4 Executive Summary 2 Financials 3 Pharmaceutical Pillar 4 Biomaterials / Medical Device Pillar 5 Appendix © 2023 GNI Group Ltd. All rights reserved 28
Slide 29: GNI Group Organization after CBIO Reverse Merger
We Bring New Hope to Patients 5. Appendix GNI Group Organization after CBIO Reverse Merger Percentage of holdings in profitable/nearly break-even subsidiaries are higher TSE:2160 *Decimal numbers of ownership ratios are rounded. GNI Group Ltd. 100％ 74％ 100％ GNI Hong Kong GNI USA Shanghai Genomics Li
Slide 30: Human Capital
We Bring New Hope to Patients 5. Appendix Human Capital Name/Year 2020 2021 2022 Beijing Continent 419 481 523 Berkeley Advanced Biomaterials 29 30 31 Cullgen San Diego 4 8 11 Cullgen Shanghai 57 78 90 Other 30 31 46 Total 539 628 701 © 2023 GNI Group Ltd. All rights reserved 30
Slide 31: Contact Information
We Bring New Hope to Patients Contact Information infojapan@gnipharma.com © 2023 GNI Group Ltd. All rights reserved 31