Slide 1: Q1 2023 Earning Result
Q1 2023 Earning Result 2023/04/28
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. Q1 2023 Operational Highlights 2. Q1 2023 Operational Overview 3. Research and Development ONIVYDE® PEP07 4. Vision for 2023 5. Q&A
Slide 4: Keep Deliver Sustainable Growth and Enhanced Value
Keep Deliver Sustainable Growth and Enhanced Value Commercial Pipeline Operation New project licensing and RD progress Operation with a sustainable growth ONIVYDE ® market and new indication accelerated 1. Approved by the Ministry of Economic Affairs 1. Poster presentation of preclinical data of exp
Slide 5: Q1 2023 Operational Overview
Q1 2023 Operational Overview
Slide 6: Sales and Royalties Drives Long-term Growth
Sales and Royalties Drives Long-term Growth NT$(000) Q1 2023 / Q1 2022 Items Year 2017 2018 2019 2020 2021 2022 YoY (%) Taiwan Sales 40,651 87,384 180,389 214,828 235,469 277,594 73,216(9%) Royalties from Europe 63,526 109,825 133,651 271,584 419,366 376,789 95,117(-11%) and Asia Milestone 749,500 9
Slide 7: Q1 2023 Financial Results
Q1 2023 Financial Results NT$ (000) Q1 2023 Q1 2022 Amount Change % Change Operating revenue 168,333 174,129 (5,796) (3.33) Operating costs 13,628 11,638 1,990 17.10 Gross profit 154,705 162,491 (7,786) (4.79) Sales expenses 9,676 7,793 1,883 24.16 G&A expenses 24,326 19,799 4,527 22.86 R&D expenses
Slide 8: Research and Development
Research and Development • 1L PDAC NDA Submission Preparation • PEP07 will Initiate Phase I in Austria in 1H 2023 • Multiple Projects Collaboration with External AI/CADD 8
Slide 9: NAPOLI-3
A randomized, Open Label Phase 3 Study of Liposomal Irinotecan + 5-FU/LV + Oxaliplatin NAPOLI-3 (NALIRIFOX) versus Nab-Paclitaxel + Gemecitabine in Treatment-naïve Patients with Metastatic Pancreatic Ductal Adenocarcinoma ♦ NALIRIFOX (n = 383) vs. Gem + NabP (n = 387), 770 patients enrolled ♦ Study
Slide 10: Frontline Regimens for Patients with Metastatic Pancreatic Cancer
Frontline Regimens for Patients with Metastatic Pancreatic Cancer Study Phase III NAPOLI 3 Phase III MPACT Phase II/III ACCORD 11 NALIRIFOX Gemcitabine + Abraxane + Drug Gemcitabine FOLFIRINOX Gemcitabine (Onivyde) Nab-Paclitaxel Gemcitabine Von Hoff et al 2013 Conroy et al 2011 Source ASCO GI 2023
Slide 11: PEP07 (CHK1 inhibitor)
PEP07 (CHK1 inhibitor) • Early-stage DDR Project Transactions Became Hotter • Poster Presentation of Preclinical Data of PEP07 at the 6th Annual DDR Inhibitors Summit 2023 • Initiate Phase I in Austria in 1H 2023
Slide 12: DNA Damage Repair: One Critical Pathway, Multiple Targets
DNA Damage Repair One Critical Pathway, Multiple Targets DDR deal transactions became hotter Pipeline Date. Licensor Licensee Target Deal Size Stage • Upfront: $65M Undisclosed x 2020.05.26 Repare BMS Discovery • Milestone: $3.0bn 10 • Royalties: high SD - Low DD Undisclosed x • Upfront: $20M 2021.0
Slide 13: PEP07 – Potential Best in Class CHK1 Inhibitor
PEP07 – Potential Best in Class CHK1 Inhibitor PEP07 is a brain penetrating oral inhibitor which is more potent, selective, specific than the competitors. Drug Stage Potency Selectivity Specificity Oral Bioavailability Acrivon (Eli Lily) Prexasertib Ph II Genetech GDC-0575 Discontinued Ph I / II GSK
Slide 14: PEP07: A Novel, Brain Penetrant Oral Chk1 Inhibitor for AML and MCL
PEP07: A Novel, Brain Penetrant Oral Chk1 Inhibitor for the Treatment of AML and MCL – 6th Annual DDR Inhibitors Summit 2023 14
Slide 15: PEP07 for Potential Combination Therapies
PEP07 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: Synergism; Blue:
Slide 16: PEP07 Early-Stage Clinical Development Strategy
PEP07 Early-Stage Clinical Development Strategy Ph1b monotherapy, dose escalation/expansion in AML and MCL Ph1b Combo, dose escalation/expansion in selected hematologic cancer, e.g., AML or MCL Ph1 monotherapy, dose escalation/expansion in advanced or metastatic solid tumor Ph1b Combo, dose escalati
Slide 17: Vision for 2023
Vision for 2023
Slide 18: Virtual Pharmaceutical Company Business Model
Virtual Pharmaceutical Company Business Model COMPUTATIONAL 18
Slide 19: Pipeline Portfolio Focus on Precision Oncology
Pipeline Portfolio Focus on Precision Oncology Pipeline Indications Lead Preclinical Phase I Phase II Phase III Approval Rights Partner 2L PDAC (US, EU, JP, TW) ★Milestone (EU/Asia) ONIVYDE® 2L PDAC (CN) ★Royalty (liposomal topoisomerase I (EU/Asia) inhibitor/irinotecan) 2L SCLC Primary Endpoint not
Slide 20: 2023: Year of Revitalization and Marching Forward
2023: Year of Revitalization and Marching Forward Growth through ONIVYDE® life cycle management 1. 1L PDAC Phase III data readout (1Q23) 2. 1L PDAC file NDA in Taiwan Advancement and growth of early-stage pipeline 1. Start PEP07 Phase 1 studies and aim in AML and MCL 2. Additional efficacy studies i
Slide 21: PharmaEngine
PharmaEngine ee tk QB