Pharmaengine, Inc. · TPEX:4162
Pharmaengine — Cathay investor conference (May 2022)
23 slides from Pharmaengine's conference presentation, May 3, 2022
Slide 1: Cathay investor conference 4162.TWO
Cathay investor conference 4162.TWO 2022/05/03 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. 1Q22 Operational Highlights 2. 1Q22 Operational Overview 3. Research and Development ONIVYDE® PEP07 (SOL-578) 4. Vision for 2022 5. Q&A
Slide 4: Keep Deliver Sustainable Growth and Enhanced Value in 1Q22
Keep Deliver Sustainable Growth and Enhanced Value in 1Q22 Commercial Pipeline Operation ONIVYDE ® market and new indication expansion New project licensing and RD progress Operation with a sustainable growth 1. ONIVYDE® 2L PDAC treatment got China NMPA accelerated 1. 1Q22 Cash and cash equivalents:
Slide 5: 1Q22 Operational Overview
1Q22 Operational Overview ONIVYDE® Revenue with Double-Digit Growth
Slide 6: Sales and Royalties Drives Long-term Growth
Sales and Royalties Drives Long-term Growth NTD $(000) Items Year 2017 2018 2019 2020 2021 1Q21/1Q22 YoY (%) Taiwan Sales 40,651 87,384 180,389 214,828 235,469 67,169 (25%) Royalties from Europe and Asia 63,526 109,825 133,651 271,584 419,366 106,960 (72%) Milestone 749,500 96,221 0 569,600 0 0 Tota
Slide 7: 1Q22 Financial Results
1Q22 Financial Results NTD$ (000) 1Q22 1Q21 Amount Change % Change Operating revenue 174,129 115,645 58,484 51 Operating costs 11,638 9,188 2,450 27 Gross profit 162,491 106,457 56,034 53 Sales expenses 7,793 5,977 1,816 30 G&A expenses 19,792 20,698 (906) (4) R&D expenses 18,274 45,435 (27,161) (60
Slide 8: Research and Development
Research and Development ONIVYDE® launched in China 2L PDAC market PEP07 (SOL-578) preclinical progress meets expectation Multiple projects under evaluation
Slide 9: ONIVYDE Keep Global Market Expansion at 2L PDAC
ONIVYDE® Keep Global Market Expansion at 2L PDAC Approved Yet approved 9
Slide 10: Spotlight of ONIVYDE 2L PDAC Approval in China
Spotlight of ONIVYDE® 2L PDAC Approval in China The first 2L PDAC new drug approved in the past 23 years ONIVYDE® has been recommended by China major treatment guidelines • THE NATIONAL HEALTH COMMISSION 'PANCREATIC CANCER DIAGNOSIS AND TREATMENT SPECIFICATIONS (2018 EDITION) • THE CHINESE SOCIE
Slide 11: ONIVYDE 2L PDAC Target Addressable Market (TAM)
ONIVYDE® 2L PDAC Target Addressable Market (TAM) The estimation of China PDAC Incidence No. (2016-2030) Indication 2L PDAC Period CAGR Incidence No. 120K 2016-2019 3.3% 2019-2024 3.2% Diagnose at stage IV (%) 60% 2024-2030 3.0% Potential to treat % 35% (Thousand ) 2022E Potential to Treat No. 25.2K
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 Meets Expectation
Slide 15: 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. 15
Slide 16: 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 17: 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 18: 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 May of 2022 Preclinical CMC Anti-tumor efficacy in two AML models and MCL model Identified novel
Slide 19: Vision for 2022
Vision for 2022
Slide 20: Virtual Pharmaceutical Company Business Model
Virtual Pharmaceutical Company Business Model 20
Slide 21: Pipeline Portfolio
Pipeline Portfolio Indications Lead Preclinical Phase I Phase II Phase III Approval Rights Partner Products 2L PDAC(US, EU, JP, TW) ★Milestone (EU/Asia) 2L PDAC (CN) ★Royalty ONIVYDE® (EU/Asia) 2L SCLC Data readout (2022) ★Taiwan Data readout (2023) Sales 1L PDAC Pathway 1 CHK1i (PEP07) TBD IND Fili
Slide 22: 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 (2023) Advancement and growth of early-stage pipeline 1. PEP07 IND/CTA
Slide 23: PharmaEngine
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