Pharmaengine, Inc. · TPEX:4162
Pharmaengine — 1H 2024 Investors' Conference
18 slides from Pharmaengine's conference presentation, Jul 31, 2024
Slide 1: 1H 2024 Investors' Conference
PharmaEngine, Inc. 4162.TWO 1H 2024 Investors’ Conference 2024/07/31 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. 1H 2024 Operational Highlights 2. 1H 2024 Operational Overview 3. Research and Development ◆ ONIVYDE® ◆ Pipeline 4. Vision for 2024 5. Q&A
Slide 4: 1H 2024 Operational Highlights: Sustainable Growth and Enhanced Pipeline
1H 2024 Operational Highlights: Sustainable Growth and Enhanced Pipeline COMMERCIAL PIPELINE OPERATION ONIVYDE® New project R&D progress Operation with sustainable Indication expansion accelerated growth In 2024, ONIVYDE® regimen 1. Phase 1 clinical trial of 1. 1H24 cash and cash (NALIRIFOX) for 1L
Slide 5: 1H 2024 Operational Overview
1H 2024 OPERATIONAL OVERIVEW
Slide 6: Sales and Royalties Drive Long-term Growth
Sales and Royalties Drive Long-term Growth NT$(000) 1H 2024 Item Year 2018 2019 2020 2021 2022 2023 YoY (%) Taiwan Sales 87,384 180,389 214,828 235,469 277,594 278,547 135,033(-7%) Royalties from 109,825 133,651 271,584 419,366 376,789 426,652 230,562 (+22%) Europe and Asia Milestone/Sub- 96,221 0 5
Slide 7: 1H 2024 Financial Results
1H 2024 Financial Results NT$(000) 1H 2024 1H 2023 Amount Change % Change Operating revenue 426,373 334,403 91,970 28% Operating costs 22,603 26,256 (3,653) (14%) Gross profit 403,770 308,147 95,623 31% Sales expenses 15,789 19,770 (3,981) (20%) G&A expenses 46,864 46,935 (71) -- R&D expenses 130,05
Slide 8: ONIVYDE Status & Market Analysis
ONIVYDE® STATUS & MARKET ANALYSIS • ONIVYDE® regimen (NALIRIFOX) for 1L PDAC received sNDA from US FDA, Australia TGA, and Taiwan TFDA, and EU EMA and has been launched in Germany • 2022 global patients with initial diagnose of pancreatic cancer: 510,991 (GLOBOCAN 2022 Data) • 2021 Taiwan patients w
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 1996 US FDA approval 2013 TFDA license 2015.3 TFDA license 2024 US FDA, Australia TGA, EU EMA 2003 NHI reimburse 2014.6 NH
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
[Rap PIPELINE
Slide 12: Pipeline Portfolio Focuses on Precision Oncology
Pipeline Portfolio Focuses 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 P
Slide 13: A New Wave of Innovations within DNA Damage Response (DDR)
A New Wave of Innovations within 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 tu
Slide 15: Synthetic Lethality
Synthetic Lethality Cancer cell Cancer cell Pathway A Pathway A Gene mutation One antitumor drug Pathway B Pathway B Gene mutation One antitumor drug Viable Lethal Pathway B Inhibition of Pathway A triggers compensatory Simultaneous inhibition of Pathway A and Pathway B Pathway B activation is letha
Slide 16: Vision for 2024
L vision FOR 2024
Slide 17: Vision for 2024
Vision for 2024 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 c
Slide 18: Thank You
THANK YOU PharmaEngine, Inc.