Filling the Therapeutic Gap

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1 Corporate Presentation (TWSE 4743) 報告人 : 合一生技國際業務處長陳瑞青博士 November 28, 2018

2 免責聲明 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 合一生技 2008 年成立 PIC/s GMP 等級藥廠 GACP 有機農場 (44 公頃 ) 2011 年上櫃 (TWSE:4743) 資本額 : 新台幣 19.6 億元核心產品 :ON101, OB318 核心生產基地 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 簡明資產負債表 ( 單位 : 千美元 ) 項目 2016/12/ /12/ /09/30 流動資產 52,308 41,244 27,849 不動產廠房及設備 5,825 15,190 18,108 無形資產其他資產 26,290 26,842 26,482 資產總額 85,189 84,046 73,266 負債總額 1, 股本 65,057 65,251 65,251 資本公積 25,714 25,486 20,391 保留盈餘 (475) (5,182) (6,821) 其他權益等 (6,154) (2,391) (6,487) 權益總額 84,142 83,164 72,334 4

5 Q3 損益表 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 核心新藥 - ON101 Globally Unmet, We Met. The Best-in-class for DFU 6

7 糖尿病足部傷口潰瘍 (DFU) 1. 全球超過 2,600 萬 DFU 患者 2. 每年新增 DFU 患者超過 850 萬人 3. 終生發生率 25%, 年復發率 30-40% 4. DFU 截肢後 5 年死亡率 40% One of major complications of diabetic patients with a chronic and costly process 7

8 巨大財政負擔 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 (%) 臨床達標第一個三期試驗期中分析 Overall Group Plantar Wounds % % % ON101 Aquacel % ON101 Aquacel Large Wounds > 5 cm % 5.9% ON101 Aquacel 10

11 顯著療效 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 二期臨床試驗結果 11

12 How does ON101 work in DFU wound healing? 12

13 作用機制 Wound Control Wound Healing 止血期 Hemostasis 發炎期 Inflammation 增生期 Proliferation 重塑期 Remodeling Vascular Constriction Clot Formation Chemotaxis Inflammation Cytokine& Growth Factor Release Angiogenesis Fibroplasia Collagenesis Epithelial healing Scar Remodeling DFU 是相當複雜的疾病, 並非單一靶向藥物可以完全治癒 ON101 由兩種藥材萃取物組成, 具有抗發炎促進血管新生促進纖維組織增生合成膠原及表皮細胞上皮化, 加速傷口癒合作用 13

專利佈局配方及用途專利保護 Topical formulation Method of treating wounds and skin disorders (2017.

14 專利佈局配方及用途專利保護 Topical formulation Method of treating wounds and skin disorders ( application) 活性成分專利保護 Use of flavonoid compound in preparation of composition for healing wound 萃取物專利保護 Plant extracts for treating skin disorders and enhancing healing of wounds for diabetic patients 製程專利保護 The process for preparing active pharmaceutical composition 14

15 優勢與市場 15

16 藥品療效優勢 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 藥品使用優勢 Revolutionary treatment. Just use at home. Now (without ON101) Ulceration Future (with ON101) Ulceration Hospital Reduced Productivity Hospital resources occupied Plateau effect Surgically expensive Hospital Home care Healed Healed 17

Acelity Cellular therapies up to $10,000, Complex management

18 l Severity of DFU + 藥品訂價優勢 A cost-effective 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

Drug Development - Guidance for Industry (2016.

19 藥品供應優勢 by streamlined control from cultivation to production We have established 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 for global supply (capacity with 50 mn tubes in 1 st stage) 44-acre GACP Cultivation Site PIC/s GMP Plant 19

20 大陸上市 - 全球最大 DFU 市場 Phase III MRCT Trial stared in 2018 NDA expected in 2019 Marketed during mn DFU patients Incidence: 8.1% 20

21 IDF 大會受邀口頭報告 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 上市計畫 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

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untitled Safe Harbor This presentation contains statements of a forward-looking nature. These statements are made under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. You