Oneness Biotech Co., Ltd. · TPEX:4743
Oneness Biotech — 2020 3rd Investor Conference
40 slides from Oneness Biotech's conference presentation, Nov 7, 2020
Slide 1: 2020 3rd Investor Conference Corporate Presentation
2020 3rd Investor Conference Corporate Presentation Science ‧ Integrity ‧ Transparency 2020.11.07
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 2020.11.07 3
Slide 4: 2019 / 2020 2nd Quarter
Items Revenue R&D Exp. Total Assets Owner’s Equity Total Liabilities Net Profit (Loss) % * % . % & & & , + ( ( * $ * $ + $ $ % , - - % & ( & & & & & ' ) ' + ' $ * - ( * ' - . ( $ ( ( K U V ! ! ) ) " & & / ( % ' $ # ' ) . $ - W * ) - , % & & , $ & & & & " % * + % . $ % ) $ * . Z , + . + ' [ 0 P V \ ]
Slide 5: Consolidated Statement of comprehensive income
Consolidated Statement of comprehensive income _ ` a b b c d e f g d h i j a k l d m n o p q r s t c e h r l b d g d u k _ v j k k w t c b k i l b c w Item 2020 Q2 2019 Q2 2020 H1 2019 H1 Operating revenue 31,665 2,186 34,910 6,370 Operating costs 3,259 4,151 6,919 8,527 Unrealized gross profit 7,06
Slide 6: Consolidated Balance Sheets
Consolidated Balance Sheets (Currency in thousand NTD) Item 2020/6/30 2020/3/31 2019/6/30 Cash, Securities and Cash in banks 3,204,851 1,543,769 559,596 Other current assets 645,045 125,434 96,692 Property, plant and equipment 620,380 630,907 591,739 Investments 2,761,494 1,359,026 705,074 Other Int
Slide 7: Summary of Consolidated Financial Statements for the Years Ended June 30, 2020
Summary of Consolidated Financial Statements for the Years Ended June 30, 2020 Summary of Net Profit NTD 487,683 thousand ： 1. Research and development expenses 183,537 thousand x Research and development expenses are used for multiple international clinical trials of new drugs, including phase I, p
Slide 8: Summary of Consolidated Financial Statements for the Years Ended June 30, 2020
Summary of Consolidated Financial Statements for the Years Ended June 30, 2020 3. Financial situation stable， important financial ratio： Current ratio Quick ratio Debts ratio 2,565.4% 2,502.9% 15.2% (Currency in thousand NTD) 4. Important assets explanation : Account for Items Amounts total assets E
Slide 9: Summary of cash capital increase
Summary of cash capital increase The plan of cash capital increase： Cash capital increase by issuing 19,100 thousand shares, the dilution percentage by issuance of new shares for global depositary shares for the shareholding of existing shareholders is only 5.09%, the fund receipt of certificate of
Slide 10: R & D Progress
R & D Progress As of 2020.11.07
Slide 11: Progress of Important New Drugs
Progress of Important New Drugs Milestones & Key Factors FB825 ON101 FB704A Ph2 Trial Result NDA & Out- Ph2 Trial licensing Indication 1 2 3 11
Slide 12: FB825-AD Progress
FB825-AD Progress Atopic Dermatitis Ph 2a in U.S. Completion of site initiation of 10 sites with 22 subjects enrolled Aim to complete recruitment of 90 subjects enrolled in February 2021 Aim to unblind data in August 2021 12
Slide 13: FB825-AD Key Factor
FB825-AD Key Factor Biomarker for Clinical Response (FB825 Responder) Atopic dermatitis (AD) is heterogeneous and patients are often with mixed types of skin disorders. Based on FACS analysis on 60 AD subjects, exploratory study on 12 subjects, biomarker study on 20 subjects (ongoing), FB825 bio
Slide 14: Biomarker - Clinical Benefits Compared with Dupilumab
Biomarker - Clinical Benefits Compared with Dupilumab (Sanofi) EASI Mean % Change from Baseline 80 74 70 60 60 50 at Day 29 40 30 30 20 10 0 Non-responders Patient Patient Responders with IgG4 >200 mg/dL with IgG4 <200 mg/dL Dupi CHRONOS FB825 1 dose/month Dupilumab 2 doses/ month14 FB825 biomarker
Slide 15: FB825-AD Patient % with Biomarker
FB825-AD Patient % with Biomarker Taiwan US Patients without biomarker 4.5% Patients Patients with without biomarker biomarker Patients with 60% 40% biomarker 95.5% 15
Slide 16: Dupixent (Sanofi)
Dupixent (Sanofi) >10 bn } ~ The accumulated sales of Dupixent in 3 quarters of 2020 has exceeded €2.55 bn and sales of this year is projected to exceed €3.4 bn . The peak sales in 2028 will reach over €10 bn of which AD accounts for €6 bn 3.4 bn 2.07 bn y z { | 220 m 2017 2018 2019 2020
Slide 17: FB825-AA Progress
FB825-AA Progress Allergic Asthma Ph2 trial in Taiwan (Sponsored by Microbio Shanghai) 2020.08 Completion of cGMP Production 2020.08 Protocol approved by TFDA approved 2020.11 Protocol amendment (ICS taper) Aim to initiate in Dec 2020 and recruit 100 subjects Aim to unblind in 2022 17
Slide 18: FB825-AA ICS Taper Design
FB825-AA ICS Taper Design W-4 W0 W4 W8 W12 W16 W20 W24 W32 FB825 Follow-up Background LABA Screen Therapy Withdrawal ICS Taper Mono (Background Therapy therapy) 4W 4W 4W 4W 4W 4W 4W 8W LABA LABA -50% ICS -50% ICS (Fluticasone-Salmeterol) -50% *Albuterol/salbutamol given as reliever
Slide 19: FB704A Progress
FB704A Progress Indication for Ph2 Trial –Severe Neutrophilic Asthma 2020.08 Data read out for Ph1 completed in U.S. : (1) FB704A is well tolerated in both healthy and RA subjects with good safety profile. (2) FB704A can effectively neutralize serum IL-6 and reduce CRP. (3) FB704A can reduce count
Slide 20: FB704A Key Factor
FB704A Key Factor Indication for Phase 2 Trial Neutrophilic Asthma(Unmet Medical Need) Dendritic Cells Dendritic Cells APC APC Eosinophilic I asthma FB704A IL-4 IL6 Benralizumab (IL5) IL6 is a key cytokine to Duplilumab (IL4R) neutrophilic asthma Meplolizumab (IL5) Omalizumab (IgE) Eosinophilic asth
Slide 21: Neutrophilic Asthma Market
Neutrophilic Asthma Market Neutrophilic Asthma (NA) Severe Neutrophilic Asthma Market patients is about 1.1 million1 The importance of neutrophilic asthma has been 160 Patients, Global, Millions 135.9 gradually recognized and server NA are 5%2 of 140 121.0 120 110.3 total NA patients which is appr
Slide 22: ON101 Progress
ON101 Progress 2020.08 Submission of CSR (212 subjects) for completing supplementation to NDA at Taiwan FDA 2020.10 Completion of Phase 3 trial site GCP inspection. Aim to complete NDA in Q4 2020 2020.10 Completion of Pre-NDA meeting with NMPA. Submission of NDA package in Nov. 2020 2020 Q4
Slide 23: ON101 Key Factor -1
ON101 Key Factor -1 Regulatory Approval in Major Markets Market entry into China: NDA submission will be made under natural drug category 1. NDA package will be submitted soon and approval is subject to the review procedure at regulatory authority. Market entries into U.S. & EU: Data under prepa
Slide 24: ON101 Key Factor -2
ON101 Key Factor -2 Global Pricing and Licensing DFU is a global disease and DFU new drug pricing shall consider global markets. Pricing strategy includes pricing analysis of U.S. (largest market) and China (3rd largest market with most DM patients and the 1st major market for market launch) as
Slide 25: Mechanism of Action
ON101 Key Factor -3 Mechanism of Action
Slide 26: ON101 MoA -1
ON101 MoA -1 DFU to Normal Wound ¡ ¢ £ ¤ ¥ ¦ 1 : < 3 I 6 « ª © ¨ § 1 : < 3 I 6 ; < = ; < = 3(control) 6 9 12 ON101 regulates specific chemokine 1 : < 3 I 6 and growth factor which guided Mφ phenotypic switch fr
Slide 27: ON101 MoA - 2
ON101 MoA - 2 Chronic Ulceration: Imbalance M1/M2 Homeostasis Inflammation Proliferation Remodeling M1 M2 The existence of excessive M1Φ in The delayed transition between DFU prolongs the inflammation M1 M2 M1/ M2 Φ will reduce and causes chronicity which 1 M1 M1 angiogenesis, keratinocyte activity,
Slide 28: ON101 MoA - 3
ON101 MoA - 3 Rebalance M1/M2 Homeostasis Inflammation ON101 Proliferation Remodeling M1 M2 Regulates Macrophage Regulates the surrounding cells Suppressed M1 polarization, promote M2 Suppressed inflammation state recruitment Promote keratinocyte proliferation & Balanced the M1/ M2 ratio M1
Slide 29: ON101 Phase 3
ON101 Phase 3 DFU Healing Factor & Hard-to-heal Ulcers Analysis
Slide 30: ON101/Aquacel Equally-distributed Baseline Characteristics
ON101/Aquacel Equally-distributed Baseline Characteristics Ulcer Location DM Complication Ulcer Etiology Amputation History Ulcer Duration Cardio-vascular Disease Ulcer Severity Diabetic Neuropathy Ulcer Size(cm2) Diabetic Kidney Disease Diabetes Type Diabetic Retinopathy DM Duration Peripheral Vasc
Slide 31: Healing Factor Analysis -1
Healing Factor Analysis -1 Wagner Grade 2 Plantar Ulcers HbA1c >7% BMI ≥ 25 Complete Healing Rate (FAS) Complete Healing Rate (FAS) Complete Healing Rate (FAS) Complete Healing Rate (FAS) 80 p < 0.0001 80 p = 0.0003 80 p = 0.007 80 p = 0.0005 » » » 60 » 60 º º 60 60 ¹ ¹ º 62.2% º ¹ ± ± ¹ ² ± ² 58.5%
Slide 32: Healing Factor Analysis -2
Healing Factor Analysis -2 Ulcer > 5 cm2 Ulcers ≥ 6 mons Smokers Neuropathy Complete Healing Rate (FAS) Complete Healing Rate (FAS) Complete Healing Rate (FAS) Complete Healing Rate (FAS) 80 p = 0.008 80 p = 0.0248 80 p = 0.0065 80 p = 0.0008 » º » ¹ 60 71% » 60 » 60 º 60 ± ¹ º ² º ¹ ¹ ´ ± 57.1% 59.
Slide 33: Hard-to-heal Ulcers Analysis – Wagner Grade
Hard-to-heal Ulcers Analysis – 1 Wagner Grade 2 Ulcer 70 57.1% 62.2% 57.1% Complete Healing Rate (%) 57.1% 58.1% 60 45.5% 50 40 37% 29.5% 30 20.7% 18.4% 20 12.5% 10 12.5% 7.7% 4.5% 0 ON101 Aquacel ON101 Aquacel ON101 Aquacel ON101 Aquacel ¼ < A @ 3 2 ½ ¾ ¼ < A @ 3 2 ½ ¾ ¼ < A @ 3 2 ½ ¾ ¼ < A @ 3 2 ½
Slide 34: Hard-to-heal Ulcers Analysis – Plantar Ulcer
Hard-to-heal Ulcers Analysis – 2 Plantar Ulcer 54.8% 53.3% 52.1% Complete Healing Rate (%) 48.6% 45.5% 36.7% 20%20.7% 20% 19.4% 17.6% 12.5% 7.7% 7.7% 0% ON101 Aquacel ON101 Aquacel ON101 Aquacel ON101 Aquacel ON101 Aquacel ON101 Aquacel Æ Ç È É Ê È Ë Æ Ç È É Ê È Ë Æ Ç È É Ê È Ë Æ Ç È É Ê È Ë Æ Ç È É
Slide 35: Hard-to-heal Ulcers Analysis – BMI
Hard-to-heal Ulcers Analysis– 3 BMI ≥ 25 70 60 57.4% 58.1% Complete Healing Rate (%) 48.6% 50.0% 50 40 30 24.6% 22.2% 20 17.6% 18.4% 10 0 7.7% ON101 Aquacel ON101 Aquacel ON101 Aquacel ON101 Aquacel ≥ ≥ ≥ ≥ é ê ë ì í é ê ë ì í é ê ë ì í é ê ë ì í û î ï ð ñ ò ð ó ô ð õ ñ ö ó ÷ ì ø í ù ú 35
Slide 36: ON101 as a Revolution for DFU Treatment
ON101 as a Revolution for DFU Treatment Debridement Debridement Dressing ON101 Remission Heal Change of DFU Treatment Guidance will Start from 2021! 36
Slide 37: Innovation = Value + Risk
ONENESS Innovation= Value+Risk
Slide 38: 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. 38
Slide 39: Q&A
ONENESS Q&A
Slide 40: Thank you
Thank you 4 Investor Conference will be held in Dec 2020 ü ý Science ‧ Integrity ‧ Transparency