Slide 1: 1Q 2024 Investors' Conference
1Q 2024 INVESTORS’ CONFERENCE 2024/04/30 Jackie Chang, Investor Relations
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. 1Q24 Operational Highlights 2. 1Q24 Operational Overview 3. Research and Development ONIVYDE® Pipeline 4. Vision for 2024 5. Q&A
Slide 4: 1Q24 Operational Highlights: Sustainable Growth and Enhanced Pipeline
1Q24 Operational Highlights: Sustainable Growth and Enhanced Pipeline COMMERCIAL PIPELINE OPERATION ONIVYDE® new New project R&D progress Operation with indication expansion accelerated sustainable growth 1. Feb. 2024: received US 1. Phase 1 clinical trial of 1. 1Q24 cash and cash FDA sNDA approval
Slide 5: 1Q24 Operational Overview
1Q24 OPERATIONAL OVERVIEW
Slide 6: Sales and Royalties Drive Long-term Growth
Sales and Royalties Drive Long-term Growth NT$(000) 1Q24 Items Year 2018 2019 2020 2021 2022 2023 YoY (%) Taiwan Sales 87,384 180,389 214,828 235,469 277,594 278,547 65,271 (-10.9%) Royalties from 109,825 133,651 271,584 419,366 376,789 426,652 99,200 (+4.3%) Europe and Asia Milestone 96,221 0 569,6
Slide 7: 1Q24 Financial Results
1Q24 Financial Results NT$(000) 1Q24 1Q23 Amount Change % Change Operating revenue 164,471 168,333 (3,862) (2%) Operating costs 11,045 13,628 (2,583) (19%) Gross profit 153,426 154,705 (1,279) (1%) Sales expenses 7,152 9,676 (2,524) (26%) G&A expenses 22,375 24,326 (1,951) (8%) R&D expenses 56,521 3
Slide 8: ONIVYDE Status & Market Analysis
ONIVYDE® STATUS & MARKET ANAYLSIS • ONIVYDE® 1L PDAC received sNDA from US FDA, Australia TGA, and Taiwan TFDA and received positive opinion from Europe EMA’s CHMP
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 2023.7 EMA accepted Type II Variation 1996 US FDA approval 2013 TFDA license 2015.3 TFDA license 1Q24 US FDA, Australia TG
Slide 10: Taiwan PDAC Therapy Market Analysis
Taiwan PDAC Therapy Market Analysis Pancreatic ductal adenocarcinoma (PDAC) First-line Treatment Gem. based regimen ONIVYDE® + FOLFIRINOX 5-Fu/LV/oxaliplatin Second-line Treatment ONIVYDE® + 5-Fu/LV Gem. based regimen Gem. based regimen Third-line Treatment ONIVYDE® + 5-Fu/LV
Slide 11: R&D Pipeline
R&D PIPELINE
Slide 12: 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 Approval Hematologic PEP07 Cancers/Solid Global (CHK1i) Tumors DNA Undisclosed Damage PEP
Slide 13: A New Wave of Innovations within the DNA Damage Response (DDR)
A New Wave of Innovations within the DNA Damage Response (DDR)
Slide 14: PEP07 Phase 1 Clinical Trials
PEP07 Phase 1 Clinical Trials dose escalation/expansion in dose finding/expansion in Ph1b hematologic cancers Ph1b selected hematologic cancers, Mono (first patient dosed in Combo e.g., AML or MCL 2023/08) dose escalation/expansion in advanced or metastatic Ph1b Ph1 dose finding/expansion in solid t
Slide 15: Vision for 2024
VISION FOR 2024
Slide 16: 2024 Goals: ONIVYDE 1L PDAC sNDA certification obtained in US, AU, and Taiwan
2024年營運目標 1 ONIVYDE® 1L PDAC sNDA certification obtained in US, AU, and Taiwan 4 One project in pipeline may reach IND ready stage (2H24) 2 ONIVYDE® 1L PDAC sNDA certification in EU (1H24) 5 Continue to advance pipeline progress toward preclinical stage 3 PEP07 Phase 1 studies in hematologic cancers
Slide 17: Thank You
THANK YOU PharmaEngine, Inc.