Oneness Biotech Co., Ltd. · TPEX:4743
Oneness Biotech — Investor Presentation (March 2020)
35 slides from Oneness Biotech's investor presentation, Mar 24, 2020
Slide 1: 2020 Q1 Investor Conference Corporate Presentation
2020 Q1 Investor Conference Corporate Presentation Science ‧ Integrity ‧ Transparency 2020.03.24
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 2019.12.31 3
Slide 4: Market Value & Financials
Market Value & Financials 2018-2019 Financials 2014-2020 Chart (NTD) Currency in (20 Mar, 2020) thousand 2019 2018 Different NTD Revenue 13,475 18,856 (5,381) R&D Exp. 238,638 94,436 144,202 Net Profit (326,261) (244,941) (81,320) Total 2,335,421 4,644,233 Assets 6,979,654 Previous Day’s Range Year’
Slide 5: Consolidated Statement of Comprehensive Income
Consolidated Statement of comprehensive income (Currency in thousand NTD) Item 2019 2018 Operating revenue 13,475 18,856 Operating costs 17,002 10,628 Gross profit (loss) from operations (3,527) 8,228 Selling expenses 760 471 Administrative expenses 68,808 45,507 Research and development expenses 23
Slide 6: Consolidated Balance Sheets
Consolidated Balance Sheets (Currency in thousand NTD) Item 2019/12/31 2018/12/31 Cash, Securities and Cash in banks 1,588,133 628,916 Other current assets 100,370 116,260 Property, plant and equipment 640,443 561,012 Investments 1,425,932 698,397 Intangible assets 2,462,470 51,925 Other assets 762,
Slide 7: Summary of Consolidated Financial Statements for 2019
Summary of Consolidated Financial Statements for the Years Ended December 31, 2019 1. Summary of Net Loss NTD 326,261 thousand ： • Oneness Biotech invests NTD 238,638 thousand to develop innovative new drugs. The current pipeline covers drugs under phase I, phase II ,and phase III development, Such
Slide 8: Summary of Consolidated Financial Statements for 2019
Summary of Consolidated Financial Statements for the Years Ended December 31, 2019 2. Financial situation stable， important financial ratio： Current ratio Quick ratio Debts ratio 2,350.3% 2,240.8% 7.5% 3. Important assets explanation : Account for total Items Amounts Explanations assets ratio Cash、S
Slide 9: R&D Progress
ONENESS R&D Progress As of 2020.03
Slide 10: ON101 New Drug for Diabetic Foot Ulcers
ON101 New Drug for Diabetic Foot Ulcers 10
Slide 11: ON101 Market Assessment-1
ON101 Market Assessment-1 Global DFU Patients 26.8 bn (GACR 25% ) >28 million 13.7 bn Amputation/yr 5.6 bn >1.2 million 2026 Market Forecast 2023 2026 >US$26 bn 2019 Source: Global Market Insight, Chronic ulcers(DFU+VLU+PU) Global market forecast exceeds US$44 bn in 2026 Source: Transparency Market
Slide 12: ON101 Market Assessment-2
ON101 Market Assessment-2 1. All phase 3 trials in DFU failed in the past 2 decades. It is evaluated that the efficacy and pharmaco-economic advantage of ON101 are better in comparison with the only approved DFU drug Regranex(J&J) and other drugs registered on clinicaltrial.gov. 2. We are developing
Slide 13: Progress of Phase 3 Trial
Progress of Phase 3 Trial Indication 236 DFU Subjects 16 weeks Taiwan, China, U.S. 2019 2020 Completion of recruitment of 236 subjects from Taiwan, China, US in Q4 2019 2nd interim analysis conducted in Q1 (212 subjects) CSR will be available in Q2 2020 and submitted for NDA. 13
Slide 14: Progress of NDA in Taiwan
Progress of NDA in Taiwan (2018~) Completed 1st interim analysis in Q3 (118 subjects) Rolling submission for NDA in Q2 2018 Completed recruitment of 236 subjects in Q4 2019 Will complete 2nd interim analysis in Q2 2020 (212 subjects) Will complete supplementation for NDA in Q2 2020 Aim t
Slide 15: Progress of NDA in China
Progress of NDA in China (2020~) Will submit NDA application based on 2nd interim analysis of ON101’s 1st Phase 3 MRCT. Conducted meetings with Drug Registration Dept. of NMPA in Q4 2019. Will apply for Pre-NDA meeting with NMPA in Q2 2020 。 Application will be filed in Q3 2020 for NDA in Ch
Slide 16: Market Potential of PA-F4 Drug Substance
Market Potential of PA-F4 Drug Substance PA-F4 drug substance approval was granted in Dec 2019 1. Considering the timeline and scale of new drug development of ON101, product commercialization in Europe, U.S., and India will be expedited by obtaining medical device license for topical dosage compose
Slide 17: ON101 Global Novel Mechanism
ON101 Global Novel Mechanism First finding of specific chemokine that accelerates DFU healing. 1.5 The significant increase of key Dosing chemokine has improved wound Wound Size (folds) (fold) ** * healing. (倍數) 1.0 30 size ON101 傷口面積 Placebo 20 Wound 0.5 10 ON101 Placebo 0.0 0 0 3 6 9 12 (days) 3(c
Slide 18: Progress of Nanchou Plant
Progress of Nanchou Plant 1. As of 2020.03, 5 batches of pilot manufacturing run and 1 validated batch have been completed. 2. Will apply for PIC/s GMP certification for the plant with drug substances and finished product production. 3. Commercial batch production is scheduled for Q4 2020. Annual pr
Slide 19: Progress of Out-licensing
Progress of Out-licensing 1. The only approved DFU drug: Regranex is priced at US$600 per tube of 15g. The pricing survey of ON101 has been conducted by internal consulting company and the pricing of ON101 will reference international pricing. 2. Out-licensing for Taiwan has been discussed with inte
Slide 20: FB825 New Drug
FB825 New Drug Atopic Dermatitis and Allergic Asthma 20
Slide 21: FB825 Market Assessment-1
FB825 Market Assessment-1 Rapid growth of global market in Atopic Dermatitis 18.3 bn Global Severe to Moderate AD Patients (GACR 11.1% ) >28 million 6.4 bn Patients with uncontrolled symptoms >15 million Market Forecast in 2027 2017 2027 GlobalData, Atopic Dermatitis: Global Drug Forecast and >US$18
Slide 22: FB825 Market Assessment-2
FB825 Market Assessment-2 1. The only approved biologic in AD: Dupixent(Sanofi) has reached US$2 bn sales in its 3rd year after launched. Sanofi has adjusted its peak sales forecast of Dupixent to over €10 bn early this year. It is believed that an outstanding biologic in AD could create significant
Slide 23: Progress of Phase 2 in US
Progress of Phase 2 in US Indication Atopic Dermatitis(AD) 90 24 weeks U.S. US AD IIb US AD IIa 2020 2021 2022 2023 Obtained 1st IRB approval and started screening in March 2020. Estimated completion of P2a: H1 2021 Estimated completion of P2b: H2 2021 23
Slide 24: Progress of Phase 2 in China
Progress of Phase 2 in China Indication Allergic Asthma(AA) 100 36 weeks China 2020 2021 2022 2023 CN AA IIa Schedule for IND submission in H1 2020 Complete contract with 1st site in H2 2020 Estimated completion in H2 2022 24
Slide 25: Novel Mechanism
Novel Mechanism 1st finding of the relationship FB825 inhibits IgE B cell and between IgE B and EASI score cytokines Statistical analysis via T-TEST FB825 is a new drug that specifically targets IgE B cells to treat allergic diseases Clinical evidence shows that various inflammatory cytokines ar
Slide 26: Progress in Subcutaneous Injection
Progress in Subcutaneous Injection Manufacturing Stability of high concentration at 2-8 degree Completion of medium scale production by CMO Toxicity Study Completion of SubQ dose tox study in monkey. Good safety profile Bioavailability of SubQ can reach 86% SubQ will apply in P2b study in 20
Slide 27: Progress of Out-licensing
Progress of Out-licensing 1. Oneness has negotiated with several global pharma companies and conducted due diligence. We will evaluate the proposal and decide future partner based on shareholder’s interest. 2. FB825 is with competitiveness to approved biologic in AD: Dupixent. The R&D capacity as we
Slide 28: FB704A Anti-IL6 Fully-human antibody
FB704A Anti- IL6 Fully-human antibody 28
Slide 29: FB704A Market Assessment
FB704A Market Assessment 33.9 bn Rheumatoid Arthritis Inhibition of IL6 has been a GACR 23.8 bn treatment strategy for RA 4.6% and is clinically validated. Development in this 2017 2025 indication can increase Fortune Business Insights clinical successfulness but this market is crowded.， 2.1 bn Ne
Slide 30: Progress of Phase 1 in US
Progress of Phase 1 in US Indication Healthy(Ia) 41 6 weeks US RA(Ib) Phase II or PI Study US Phase Ib 2019 2020 2021 2022 Completed Ia study in healthy volunteers with no SAE. Started Ib in RA after safety evaluation Further evaluation on future trial will be done after completion of Ib study
Slide 31: Inhibition of Liver Cancer Cells
Inhibition of Liver Cancer Cells Anti-inflammation Inhibition of Liver Cancer Better than Marketed Drug Metastasis Anti-inflammation in-vitro study Control group with metastatic cells Control F704A Tumor cell metastasis is inhibited after treatment by FB704A 31
Slide 32: New Indication for FB704A
New Indication for FB704A 1st or 2nd line of liver cancer drugs are with 10-20% response rate in treatment. Drug resistance, recurrence, and metastasis are closely related to IL-6 Combination of FB704A with liver cancer drug can increase drug sensitivity to 40%. Oneness has planned an animal s
Slide 33: Conclusion-1
Conclusion-1 Oneness has effectively invested money in R&D and kept sufficient cash flow for new drug development at the same time. Oneness has strong pipeline including AD drug or new drug/medical device that can satisfy unmet medical need in chronic ulcers. Oneness also has technology platform
Slide 34: Conclusion-2
Conclusion-2 1 out-licensing transaction per year is our goal for 2020-2022: 2020- FB825；2021-ON101；2022-FB704A We have the R&D supported by out-licensing new drug to create a cash flow for the company. The commercialization of ON101 new drug with Nanchou plant’s production capacity to keep Onen
Slide 35: Thank you
Thank you 2nd Investor Conference will be held in June 2020 Science ‧ Integrity ‧ Transparency