Slide 1: 3Q 2023 Financial Results
3Q 2023 Financial Results 2023/11/02
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. 3Q 2023 Operational Highlights 2. 3Q 2023 Operational Overview 3. Research and Development ONIVYDE® PEP07 4. Vision for 2024 5. Q&A
Slide 4: 3Q 2023 Operational Highlights - Keep Deliver Sustainable Growth and Enhanced Value
3Q 2023 Operational Highlights- Keep Deliver Sustainable Growth and Enhanced Value COMMERCIAL PIPELINE OPERATION New project RD Operation with a ONIVYDE® market and progress accelerated sustainable growth new indication expansion 1. Phase 1 clinical studies of PEP07 1. Approved by the Ministry of 1.
Slide 5: 3Q 2023 Operational Overview
3Q 2023 Operational Overview
Slide 6: Sales and Royalties Drives Long-term Growth
Sales and Royalties Drives Long-term Growth NT$(000) 3Q 2023/3Q 2022 Items Year 2017 2018 2019 2020 2021 2022 YoY (%) Taiwan Sales 40,651 87,384 180,389 214,828 235,469 277,594 216,084 (+2%) Royalties from Europe 63,526 109,825 133,651 271,584 419,366 376,789 301,791 (6%) and Asia Milestone 749,500
Slide 7: 1Q-3Q 2023 Financial Results
1Q-3Q 2023 Financial Results NT$(000) 1Q-3Q 2023 1Q-3Q 2022 Amount Change % Change Operating revenue 580,345 495,910 84,435 17.03 Operating costs 37,860 37,416 444 1.19 Gross profit 542,485 458,494 83,991 18.32 Sales expenses 28,650 29,111 (461) (1.58) G&A expenses 70,470 74,226 (3,756) (5.06) R&D e
Slide 8: Research and Development
Research and Development • ONIVYDE® 1L PDAC NDA submission • 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: 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: 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 11: 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 12: 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 13: Vision for 2024
Vision for 2024 13
Slide 14: Virtual Pharmaceutical Company Business Model
Virtual Pharmaceutical Company Business Model
Slide 15: 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 16: Continuous Advancement of Pipelines
Continuous Advancement of Pipelines ONIVYDE® 1L PDAC NDA certification in TW & EU (1H24) PEP07 Phase 1 studies in AML/MCL and solid tumors continue 2023-2024 One project in pipeline may reach IND ready stage (2H24) Continue to advance pipeline progress toward preclinical stage Complete initial scope
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