Pharmaengine, Inc. · TPEX:4162
Pharmaengine — Yuanta Investor Conference 2022
25 slides from Pharmaengine's conference presentation, Mar 10, 2022
Slide 1: Yuanta investor conference 4162.TWO
Yuanta investor conference 4162.TWO 2022/03/10 Hong-Ren Wang, Ph.D. President and CEO
Slide 2: Disclaimer
Disclaimer This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes,’ ‘expects,’ ‘anticipates,’ ‘projects,’ ‘intends,’ ‘should,’ ‘seeks,’‘estimates,’ ‘future,’ or similar expressions or by discussion of, among other
Slide 3: Agenda
Agenda 1. FY21 Operational Highlights 2. FY21 Operational Overview 3. Research and development ONIVYDE® PEP07 (SOL-578) 4. Vision for 2022 5. Q&A
Slide 4: Management Team with International Experience
Management Team with International Experience 15+ years of pharmaceutical industry experience. In addition to new drug President & CEO development, worked on novel drug delivery/device combination through drug Dr. Hong-Ren Wang evaluation, PK/device combination modeling, and novel formulation design
Slide 5: International Drug Development Consultants
International Drug Development Consultants Hagop Youssoufian, MSC, MD Former Chief Medical Officer at BIND Therapeutics Chia-Chi Lin, MD Alex Vo, Ph.D. Professor, Graduate Institute of Clinical Medicine, Executive Director, DMPK, Preclinical NTUCM ; Attending Physician, NTUH Science, Atea Pharmaceut
Slide 6: Keep Deliver Sustainable Growth and Enhanced Value in 2021
Keep Deliver Sustainable Growth and Enhanced Value in 2021 Commercial Pipeline Operation 1. ONIVYDE® 2L PDAC treatment got 1. PEP07 preclinical progress as expectation 1. +20% non-GAAP revenue as RD expenses reimbursements in Korea. 2. Early stage projects entering evaluation 2. FY21 Cash and cash e
Slide 7: FY21 Operational Overview
FY21 Operational Overview ONIVYDE® EU/Asia Royalties with strong growth momentum
Slide 8: Sales and Royalties Drives Long-term Growth
Sales and Royalties Drives Long-term Growth NTD $(000) Items Year 2017 2018 2019 2020 2021 20/21 YoY (%) Taiwan Sales 40,651 87,384 180,389 214,828 235,469 9.6% Royalties from Europe and Asia 63,526 109,825 133,651 271,584 419,366 54.4% Milestone 749,500 96,221 0 569,600 0 - Total 853,677 293,430 31
Slide 9: FY21E Financial Results
FY21E Financial Results NTD$ (000) 2021 2020 Amount Change % Change Operating revenue 654,835 1,056,012 (431,273) (38) Operating costs 37,073 37,234 (161) (0.4) Gross profit 617,762 1,018,778 (401,016) (39) Sales expenses 36,731 37,115 (384) (1) G&A expenses1 81,885 76,230 5,440 7 R&D expenses 136,8
Slide 10: Research and development
Research and development ONIVYDE® with favorable Life Cycle Management PEP07 (SOL-578) preclinical progress as expected Multiple projects entering evaluation process
Slide 11: ONIVYDE Has Strong Growth Momentum in Global at 2L PDAC
ONIVYDE® Has Strong Growth Momentum in Global at 2L PDAC EU 30,000Pts. US Asia 11,000 Pts. 27,000Pts. FY21 US Sales FY21 Sales & Royalties US$ 145M, +7% YoY US$ 22.3M, +34.6% YoY Approved Yet approved 11 Patients are prescribed 3-4 vials of Onivyde every two weeks, with an average four-month regimen
Slide 12: ONIVYDE LCM: Expansion into New Tumor Types Globally
ONIVYDE® LCM: Expansion into New Tumor Types Globally LCM: Life cycle management; PDAC: Pancreatic ductal adenocarcinoma; SCLC: Small cell lung cancer; DoT: Duration of treatment; 1L: First line; 2L: Second line; 1. 12 IQVIA APLD claims, September 2020 ; 2. Expected submission dates ; 3. Risk adjust
Slide 13: ONIVYDE: Potential to Establish Standard of Care in Hard to Treat Cancers
ONIVYDE® : Potential to Establish Standard of Care in Hard to Treat Cancers 1L PDAC 2L SCLC 5Y survival rate only 7% 5Y survival rate only 6% Significant need for more effective Very few FDA approved therapies, therapies with reduced toxicity highlighting need for new options Ability to build on suc
Slide 14: PEP07 (SOL-578)
PEP07 (SOL-578) Preclinical progress as expectation
Slide 15: International Collaboration
International Collaboration 15
Slide 16: PEP07 (SOL-578) – Best in Class CHK1 Inhibitor
PEP07 (SOL-578) – Best in Class CHK1 Inhibitor PEP07 (SOL-578) is a brain penetrating oral inhibitor which is more potent, selective and specific. 16
Slide 17: PEP07 (SOL-578): Significant Efficacy in Hematologic Malignancies
PEP07 (SOL-578) : Significant Efficacy in Hematologic Malignancies as Monotherapy and Combination therapy Acute Myeloid Leukemic (AML) Ara-C Sensitive Ara-C Resistant THP-1 tumor size 1500 Vehicle 2-on/5-off x 4 cycles Vehicle 2500 10 ml/kg BID (3on/4off)x4 PO (mm^3) Tumor Volume (mm3) Vehicle 150 m
Slide 18: PEP07 (SOL-578) for Potential Combination Therapies
PEP07 (SOL-578) for Potential Combination Therapies In vitro Combo treatment SoC agents Indication Cell line Ara-C AML MV4-11 / THP-1 Gemcitabine NSCLC NCI-H1703 5-Fu Esophagus KYSE-270 5-Fu Stomach MKN-45, SNU-16, SNU-5, 5-Fu CRC DLD-1, HT-29, SW480 TMZ Brain IMR-32 Sorafenib RCC A498 Green: Synerg
Slide 19: PEP07 (SOL-578) Early Clinical Development Plan
PEP07 (SOL-578) Early Clinical Development Plan 19
Slide 20: PEP07 (SOL-578) IND Development Plan
PEP07 (SOL-578) IND Development Plan 2021 2022 Development Plan 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 Preclinical Development CMC Development Toxicology Development IND Preparation/ Submission February of 2022 Preclinical CMC Anti-tumor efficacy in two AML models and MCL model Identified n
Slide 21: Vision for 2022
Vision for 2022
Slide 22: Virtual Pharmaceutical Company Business Model
Virtual Pharmaceutical Company Business Model 22
Slide 23: Pipeline Portfolio
Pipeline Portfolio 23 1. DDR: DNA Damage Response (BRCA1/2, CHK1/2, WEE1, etc…)
Slide 24: 2022: Year of Revitalization and Marching Forward
2022: Year of Revitalization and Marching Forward Growth through ONIVYDE® life cycle management 1. 2L PDAC get approval and reimbursement in additional countries 2. 2L SCLC Phase III data readout 3. 1L PDAC Phase III data readout (2022/2023) Advancement and growth of early-stage pipeline 1. PEP07 IN
Slide 25: PharmaEngine
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