Corporate Presentation (TWSE 4743) Presented by Dr. Jui-Ching Chen, BD Director

Transcription

1 Corporate Presentation (TWSE 4743) Presented by Dr. Jui-Ching Chen, BD Director November 28, 2018

2 Disclaimer The statements and contents included in this presentation that are not historical in nature are forward-looking statements. These forward-looking statements, which may include statements regarding our future results of operations, performance, financial condition, development or marketing of our products or business prospects, are subject to risks and uncertainties and are based on our current expectations. Actual results may differ materially from those expressed or implied in these forward-looking statements for a variety of reasons. Please be cautioned not to place undue reliance on these forward-looking statements which are based on information currently available. Our forward-looking statements at this time does not create any duty of disclosure beyond that which is imposed by law, and we expressly disclaim any obligation to publicly update or revise any forecasts or forward-looking statements, whether as a result of new information, future events or otherwise. 2

3 ONENESS BIOTECH Founded in 2008 Listed company in 2011 Capital:1.96 Billion NT Pipelines:ON101, OB318 PIC/s GMP GACP farm (44 acres) Product Indication Phase I Phase II Phase III NDA Note Preclinical Best-inclass Unmet medical Need ON101 Diabetic Foot Ulcer (DFU) IND- TW/CN/US OB318 Hepatocellular Carcinoma IND-US/TW 3

4 Consolidated Balance Sheets Item 2016/12/ /12/ /09/30 Current assets 52,308 41,244 27,849 Property, plant and equipment (Currency in thousand USD) 5,825 15,190 18,108 Intangible assets Other assets 26,290 26,842 26,482 Total assets 85,189 84,046 73,266 Total liabilities 1, Share capital 65,057 65,251 65,251 Capital surplus 25,714 25,486 20,391 Retained earnings (475) (5,182) (6,821) Other equity (6,154) (2,391) (6,487) Total equity 84,142 83,164 72,334 4

5 Market Value & Financials Q3 Financials Chart (NTD) Currency in thousand USD 2018.Q Revenue R&D Exp. 1,710 2,181 2,089 Net Profit -6,580-5, Total Assets 73,266 84,046 85,189 Liabilities ,047 Previous Close Day s Range 52-week Range Market Cap Owner s Equity 72,334 83,164 84, Mn 22 Nov 2018 (Currency in USD) 5

6 Core Asset - ON101 Globally Unmet, We Met. The Best-in-class for DFU 6

7 DFU (Diabetic Foot Ulcer) problems >26 million DFUs worldwide >8.5 million new ulcers every year 65% ulcers remain unhealed in 12 months 30-40% recurrence every year One of major complications of diabetic patients with a chronic and costly process 7

8 Huge Financial Burden Global expenditure > US$60 bn Europe U.S. MENA China India Current Treatment Cost (USD) $ 13,561 $ 11,710 $ 3,100 $ 3,000 $ 1,960 DFU Population 2,960,000 3,920,000 1,297,000 7,500,000 8,460,000 8

9 1 st Proven-efficacy among global phase III trials Drug ON101 Cream Company Current Phase III Trials Oneness Biotech Co., Ltd Development Status 1 st Phase III with interim results Category ALLO-ASC-DFU Anterogen Co., Ltd Phase III ongoing ADSC Botanical Drug DermaPro CytoTools AG Phase III ongoing Small Molecule VM202 ViroMed Co., Ltd Phase III ongoing Gene Therapy Granexin Gel FirstString Research, Inc Phase III ongoing Peptide Phase III Trials failed in the past 3 years Drug Company Year of Failure Category DSC-127 Derma Sciences, Inc Peptide CureXcell Macrocure Ltd Cell Therapy Cogenzia Innocoll, Inc Small Molecule BioChaperone Adocia 2016 PDGF Locilex Dipexium Pharmaceuticals, Inc Peptide 9

10 Complete Healing Rate (%) Achieved primary endpoint in 1 st Phase III Interim Analysis Overall Group Plantar Wounds % % % ON101 Aquacel % ON101 Aquacel Large Wounds > 5 cm % 5.9% ON101 Aquacel 10

11 Outstanding Efficacy DM > 10 yrs, Ulcer duration 2 months, Wound size 5.76 cm 2, Completely healed with in 8 weeks 5.76 cm cm cm 2 0 Weeks 2 Weeks 4 Weeks 8 Weeks Note: Phase II clinical result 11

12 How does ON101 work in DFU wound healing? 12

13 MOA Wound Control Wound Healing Hemostasis Inflammation Proliferation Remodeling Vascular Constriction Clot Formation Chemotaxis Inflammation Cytokine& Growth Factor Release Angiogenesis Fibroplasia Collagenesis Epithelial healing Scar Remodeling The complexity of DFU makes single-target drug failed to be consistently effective ON101 is strategically composed of 2 plant-derived extracts to tackle this problem by its function in anti-inflammation, promoting angiogenesis, collagen synthesis, and re-epithelization. 13

14 Global IP Protection Formulation and Clinical Use Topical formulation Method of treating wounds and skin disorders Active Ingredient Protection Use of flavonoid compound in preparation of composition for healing wound Plant Extracts Protection Plant extracts for treating skin disorders and enhancing healing of wounds for diabetic patients Manufacturing Process Protection The process for preparing active pharmaceutical composition 14

15 Competitivness & Market 15

16 Best in class 70% 60% 50% 40% 30% 20% 10% Wound Closure Rate ON % REGRANEX (J&J), 37% Aquacel, 32.2% Placebo Gel, 28% 0% Week 2 Week 4 Week 6 Week 8 Week 10 Week 12 Week 14 (Source: ON101 1 st Phase III Interim Analysis & Regranex Pivotal Trial) 16

17 Incomparable compliance Revolutionary treatment. Just use at home. Now (without ON101) Ulceration Future (with ON101) Ulceration Hospital Hospital Reduced Productivity Hospital resources occupied Plateau effect Surgically expensive Home care Healed Healed 17

18 l Severity of DFU + Cost-effectiveness A treatment for DFU Organogenesis Smith & Nephew Urgo, Convatec, Molnlycke, Acelity Cellular therapies up to $10,000, Complex management Regranex $600, Only FDA approved product Dressing up to $200 18

19 High Margin by streamlined control from cultivation to production We have established 44-acre GACP Cultivation Site A GACP site for mass cultivation of the raw material In compliance with US FDA Botanical Drug Development - Guidance for Industry ( ) PIC/s GMP Plant PIC/s GMP plant for global supply (capacity with 50 mn tubes in 1 st stage) 19

20 1 st Market Launch Global largest DFU Market Phase III MRCT Trial stared in 2018 NDA expected in 2019 Marketed during mn DFU patients Incidence: 8.1% 20

21 Breakthrough Results to be Presented Title: First new drug with over 60% complete wound closure in diabetic foot ulcers from phase III trial interim analysis report Presenter: Min-Liang Kuo, Ph.D. 21

22 Marketing Strategy From 2019 Europe $15 bn U.S. $13-15 bn India $13 bn China, TW $22 bn Execute 2019 Accelerate 2020 Expand 2021 Globaliza -tion 22

23 Globalization by Innovation 23