Slide 1: 1H 2023 Earnings Result
1H 2023 Earnings Result 2023/08/01
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. 1H 2023 Operational Highlights 2. 1H 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 ONIVYDE ® market and new indication New project RD progress accelerated Operation with a sustainable growth expansion 1. Phase 1 clinical study of PEP07 approved by 1. Approved by the Ministry of Economic Affairs 1. Tai
Slide 5: 1H 2023 Operational Overview
1H 2023 Operational Overview
Slide 6: Sales and Royalties Drives Long-term Growth
Sales and Royalties Drives Long-term Growth NT$(000) 1H 2023/1H 2022 Items Year 2017 2018 2019 2020 2021 2022 YoY (%) Taiwan Sales 40,651 87,384 180,389 214,828 235,469 277,594 144,639 (+7%) Royalties from Europe 63,526 109,825 133,651 271,584 419,366 376,789 189,764 (-8%) and Asia Milestone 749,500
Slide 7: 1H 2023 Financial Results
1H 2023 Financial Results NT$(000) 1H 2023 1H 2022 Amount Change % Change Operating revenue 334,403 341,028 (6,625) (1.94) Operating costs 26,256 23,948 2,308 9.64 Gross profit 308,147 317,080 (8,933) (2.82) Sales expenses 19,770 15,807 3,963 25.07 G&A expenses 46,935 45,405 1,530 3.37 R&D expenses
Slide 8: Research and Development
Research and Development • 1L PDAC NDA Submission • PEP07 will Initiate Phase I in Australia and Taiwan in 2H 2023 • Multiple Projects in 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 Australia and Taiwan in 2H 2023
Slide 12: DDR Deal Transactions Heat Up
DDR Deal Transactions Heat Up Date Licensor Licensee Target Pipeline Stage Deal Size • Upfront: $65M Undisclosed x 2020.05.26 Repare BMS Discovery • Milestone: $3.0bn 10 • Royalties: high SD - Low DD • Upfront: $16.3M Ribon 2021.02.02 Ono PARP7 Phase I • Milestone: $132M Therapeutics • Japan, South
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 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 Continuous Advancement of Pipelines
2023 Continuous Advancement of Pipelines Growth through ONIVYDE® life cycle management 1. 1L PDAC Phase III data readout (202301) 2. 1L PDAC file NDA in Taiwan (202306) Advancement and growth of early-stage pipelines 1. Initiate PEP07 Phase I studies in AML/MCL and solid tumors 2. Additional efficac
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