Oneness Biotech Co., Ltd. · TPEX:4743
Oneness Biotech — Investor Presentation (June 2020)
28 slides from Oneness Biotech's investor presentation, Jun 22, 2020
Slide 1: 2020 2nd Investor Conference Corporate Presentation
2020 2nd Investor Conference Corporate Presentation Science ‧ Integrity ‧ Transparency 2020.06.22
Slide 2: Forward-looking Statement
Forward-looking Statement This presentation contains forward looking statements. All statements other than statements of historical facts included in this presentation, including, without limitation, those regarding our financial position, business strategy, plans and objectives of management for
Slide 3: Financial Report
Financial Report As of 2020.6.22 3
Slide 4: Market Value & Financials
Market Value & Financials 2019-2020 Q1 Financials 2014-2020 Chart (NTD) Currency in (19 Jun, 2020) thousand 2020Q1 2019Q1 Different NTD Revenue 3,245 4,184 (939) R&D Exp. 120,785 24,239 96,546 Net Loss 191,597 30,379 161,218 Total Assets 6,868,730 2,711,995 4,156,735 Previous Total Day’s Range Year’
Slide 5: Consolidated Statement of comprehensive income
Consolidated Statement of comprehensive income (Currency in thousand NTD) Item 2020 Q1 2019 Q1 Operating revenue 3,245 4,184 Operating costs 3,660 4,376 Gross profit (loss) from operations (415) (192) Selling expenses 115 114 Administrative expenses 23,706 13,151 Research and development expenses 12
Slide 6: Consolidated Balance Sheets
Consolidated Balance Sheets (Currency in thousand NTD) Item 2020/3/31 2019/12/31 2019/3/31 Cash, Securities and Cash in 1,543,769 1,588,133 664,278 banks Other current assets 125,434 100,370 98,944 Property, plant and 630,907 640,443 572,583 equipment Investments 1,359,026 1,425,932 715,836 Other In
Slide 7: Summary of Consolidated Financial Statements for the Years Ended March 31, 2020
Summary of Consolidated Financial Statements for the Years Ended March 31, 2020 1. Summary of Net Loss NTD 191,597 thousand ： • Oneness Biotech invests NTD 120,785 thousand to develop innovative new drugs. The current pipeline covers drugs under phase I, phase II ,and phase III development, Such R&D
Slide 8: Summary of Consolidated Financial Statements for the Years Ended March 31, 2020
Summary of Consolidated Financial Statements for the Years Ended March 31, 2020 2. Financial situation stable， important financial ratio： Current ratio Quick ratio Debts ratio 2,058.9% 1,972.7% 9.4% 3. Important assets explanation : Account for total Items Amounts Explanations assets ratio The funds
Slide 9: R&D Progress
ONENESS R&D Progress As of 2020.6.22
Slide 10: Growth Foundation
Growth Foundation FB825 ON101 4/15 6/15 Licensing Deal Positive Ph3 Data 10 新聞圖片來源: ExtremeTech
Slide 11: FB825 Global Licensing
FB825 Global Licensing 530 million deal package with upfront payment of US$40M+milestone payments of US$490M+high single-digit to double digit royalties 1st milestone achieved under global profitability strategy Performing AD trial in US with high quality and standard Win-win partnership by pe
Slide 12: FB825 Progress
FB825 Progress Upfront payment of US$18.48M, the remaining $15.12M will be made upon agreed timeline. 1st patient has been dosed in AD trial in US. Aim to complete the trial in 2021. Subjects for P2a Asthma trial will be enrolled from Taiwan executed by MBS in collaboration with CRO. Aim to co
Slide 13: FB825 Key Elements
FB825 Key Elements Ph2a Trial Progress in US 1. Clinical endpoints 2. Risk management for US pandemic
Slide 14: ON101 Successful Ph3 Results
ON101 Successful Ph3 Results 1st DFU drug met primary endpoint among global trials in 23 years 1st new drug with positive Ph3 results which achieved the 2nd milestone under global profitability strategy 2 key efficacy endpoints indicate ON101’s statistical superiority in healing. Safety profile
Slide 15: ON101 Phase 3 Topline Data
ON101 Phase 3 Topline Data Primary Endpoint Secondary Endpoint Safety Complete Healing Rate (FAS) Time to Complete Healing (FAS) Treatment Emergent Adverse Event (FAS) 80 P value = 0.0001 P value = 0.001 80 P value = 0.1968 Complete Healing Rate Incidence of Related (a < 0.03476 ) 60 62.2% 60 TEAE(%
Slide 16: ON101 vs. Regranex
ON101 vs. Regranex Best Healing Efficacy in Ulcers >5cm2 Regranex Ulcer area Complete Healing Rate in 20 weeks 1 cm2 53.1% 1.25 cm2 51.2% 2 cm2 45.7% 3 cm2 38.8% 67% 4 cm2 31.9% 5 cm2 25.8% 57% Regranex 20wks Complete Healing 50% ON101 16wks Complete Healing 62% Smiell JM, Wieman TJ, Steed DL, Perry
Slide 17: ON101 Progress
ON101 Progress 2020.07 Pre-NDA meeting application with NMPA for NDA 2020.07 Final CSR will be submitted to TFDA for NDA 2020.07 Medical device registration application with US FDA 2020.08 Publication drafting for clinical data and novel mechanism Aim to complete NDA in 2020 with TFDA To
Slide 18: ON101 Key Elements
ON101 Key Elements NDA progress in Taiwan and China US, EU, India market access under medical device registration Pricing strategy for new drug/medical device Market channel and operation in global markets Global licensing negotiation
Slide 19: 2 Cornerstones for Oneness
2 Cornerstones for Oneness Oneness R&D capability and credibility have been recognized by global pharma through licensing of FB825. This helps Oneness future licensing negotiation. Ph3 results of ON101 are important milestone for market launch. ON101 as a potential blockbuster new drug will be a
Slide 20: FB704A Progress
FB704A Progress New Indications The results of in-vivo study combining FB704A with 1st line drug in liver cancer didn’t reflect 2.5 bn statistical significance GACR Systemic inflammatory diseases 1.6 bn 6.0% Systemic sclerosis is systemic 2018 2026 inflammatory disease addressed 20 by no biolo
Slide 21: Progress of R&D Drugs
Progress of R&D Drugs OB318 (HCC new drug) Optimize the fermentation process and safety study 2020.06.29 kickoff phase 1 clinical study enrolled 30 late stage HCC patients. Estimated time to finish study in 2021. FB918 (mAb for allergic asthma) Regulate Th1/Th2 cytokines to inhibit inflamm
Slide 22: Issue of Depositary Receipts
Issue of Depositary Receipts
Slide 23: Estimate the cost to develop a new drug at US$1.3Bn
Estimate the cost to develop a new drug at US$1.3Bn Sanofi cost 6 Billion USD in developing Dupixent (AD new drug) Estimated more than $6B sales in 2021 Source: Jonathan Gardner, BioPharma Dive, Published on 3 Mar. 2020. 23
Slide 24: DR Issuance
DR Issuance 2020.06 Issue of DR has been approved in shareholders’ meeting Purpose of DR : Keep sufficient funding for future R&D. This is to expand future R&D pipeline based on Oneness’ strong R&D capability. Purpose and use of the fund by issuing DR will be applied with financial authority
Slide 25: Innovation = Value + Risk
ONENESS Innovation= Value+Risk
Slide 26: New Drug R&D: Investment and Risk
New Drug R&D: Investment and Risk High Risk Area (High innovation=High value=High Risk) 10000-20000 500 10 1 Compounds Candidates Drugs Approval 1-2 yr 3-5 years 1-2 yr 6-10 yr 1-2 yr Pre- Discovery Ph1 Ph1 Ph2 Ph3 NDA clinical Investment Risk 資料來源: Drug Discovery Timeline Graphic, https://www.resea
Slide 27: Final Note on Investment Risk
Final Note on Investment Risk Investment in R&D biotech companies is with huge risk and can’t guarantee returns or dividends within a short period of time. Investors shall understand the nature and operation of the companies before making investment. 27
Slide 28: Thank you
Thank you 3rd Investor Conference will be held in Sept 2020 Science ‧ Integrity ‧ Transparency 28