Slide 1: 4Q 2023 Financial Results
4Q 2023 Financial Results 2024/03/05
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. 2023 Operational Highlights 2. 2023 Operational Overview 3. Research and Development ONIVYDE® PEP07 4. Vision for 2024 5. Q&A
Slide 4: 2023 Operational Highlights - Keep Delivering Sustainable Growth and Enhanced Value
2023 Operational Highlights- Keep Delivering Sustainable Growth and Enhanced Value Commercial Pipeline Operation ONIVYDE® market and new New project R&D progress Operation with a sustainable growth indication expansion accelerated 1. Approved by the Ministry of 1. Taiwan FDA sNDA submission 1. Phase
Slide 5: 2023 Operational Overview
2023 Operational Overview
Slide 6: Sales and Royalties Drives Long-term Growth
Sales and Royalties Drives Long-term Growth NT$(000) 2023 YTD Items Year 2017 2018 2019 2020 2021 2022 YoY (%) Taiwan Sales 40,651 87,384 180,389 214,828 235,469 277,594 278,547 (0%) Royalties from Europe 63,526 109,825 133,651 271,584 419,366 376,789 426,652 (+13) and Asia Milestone 749,500 96,221
Slide 7: 2023 Financial Results
2023 Financial Results NT$(000) FY2023 1Q-3Q 2022 Amount Change % Change Operating revenue 767,669 654,383 113,286 17% Operating costs 48,697 49,699 (1,002) (2%) Gross profit 718,972 604,684 114,288 19% Sales expenses 38,538 45,104 (6,566) (15%) G&A expenses 92,970 94,960 (1,990) (2%) R&D expenses 3
Slide 8: Research and Development
Research and Development • ONIVYDE® 1L PDAC NDA submission status • First patient dosed in PEP07 phase 1 for hematologic cancers • PEP07 phase 1 for solid cancer approved by TFDA • Multiple projects in collaboration with external AI/CADD
Slide 9: Development of Pancreatic Cancer Therapy in Taiwan
Development of Pancreatic Cancer Therapy in Taiwan Gemzar TS-1 Abraxane 1L ONIVYDE® (Gemcitabine) TTY BMS/Celgene PharmaEngine Eli Lilly 2002 Japan approval 2013 US FDA approval 2023.6 TFDA accepted sNDA 1996 US FDA approval 2013 TFDA license 2015.3 TFDA license 2023.7 EMA accepted Type II Variation
Slide 10: Taiwan PDAC Therapy Market Analysis
Taiwan PDAC Therapy Market Analysis Pancreatic ductal adenocarcinoma (PDAC) First-line Treatment Gem. based regiment FOLFIRINOX ONIVYDE® + 5-FU/LV/oxaliplatin Second-line Treatment ONIVYDE® + 5-Fu/LV Gem. based regiment Gem. based regiment Third-line Treatment ONIVYDE® + 5-Fu/LV
Slide 11: 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 and selective than the competitors. Drug Stage Potency Selectivity Oral Bioavailability Acrivon (Eli Lily) Prexasertib Ph II Genetech GDC-0575 Discontinued Ph I / II GSK (Sierra Oncology)
Slide 12: 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 13: PEP07 Early-Stage Clinical Development Strategy
PEP07 Early-Stage Clinical Development Strategy dose escalation/expansion in Ph1b dose escalation/expansion in Ph1b selected hematologic cancer, Mono AML and MCL Combo e.g., AML or MCL dose escalation/expansion in Ph1 Ph1b dose escalation/expansion in advanced or metastatic Mono Combo selected solid
Slide 14: Vision for 2024
Vision for 2024 14
Slide 15: Virtual Pharmaceutical Company Business Model
Virtual Pharmaceutical Company Business Model
Slide 16: Pipeline Portfolio Focus on Precision Oncology
Pipeline Portfolio Focus on Precision Oncology Commercial Program Indications Lead Preclinical Phase I Phase II Phase III Approval Partner Rights 2L PDAC Approval ONIVYDE® EU/Asia (liposomal irinotecan) 1L PDAC Primary Endpoint met (2022/11) PEP07 AML/Solid Tumors Global (CHK1i) DDR DNA PEP09 Undisc
Slide 17: Continuous Advancement of Pipelines and ESG Activities
Continuous Advancement of Pipelines and ESG Activities ONIVYDE® 1L PDAC NDA certification obtained in the US; TW 01 & EU results expected in 1H24 02 PEP07 Phase 1 studies in AML/MCL and solid tumors continue 2024~ 03 One project in pipeline may reach IND ready stage (2H24) 04 Continue to advance pip
Slide 18: PharmaEngine
PharmaEngine ee tk QB
Slide 19: 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