Slide 1: 3Q24 Investors' Conference
PharmEngine, Inc. 4162.TWO 3Q24 Investors’ Conference 2024/11/05 ChiHsing Chang, Vice President/Spokesperson
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 2024 Operational Highlights 2. 3Q 2024 Operational Overview 3. Commercial Product ◆ ONIVYDE® ◆ LIPORAXEL ® 4. R&D Pipeline 5. Vision for 2025 6. Q&A
Slide 4: 3Q 2024 Operational Highlights: Sustainable Growth and Enhanced Pipeline
3Q 2024 Operational Highlights: Sustainable Growth and Enhanced Pipeline COMMERCIAL PIPELINE OPERATION ONIVYDE® New project R&D progress Operation with Indication expansion accelerated sustainable growth 1. In 2024, ONIVYDE® regimen 1. PEP07 Phase 1 for 1. 3Q24 cash and cash (NALIRIFOX) for 1L PDAC
Slide 5: 3Q 2024 Operational Overview
3Q 2024 OPERATIONAL OVERVIEW
Slide 6: Sales and Royalties Drive Long-term Growth
Sales and Royalties Drive Long-term Growth NT$(000) 3Q 2024/3Q 2023 Item Year 2018 2019 2020 2021 2022 2023 YOY (%) Taiwan Sales 87,384 180,389 214,828 235,469 277,594 278,547 211,723 (-2%) Royalties from 109,825 133,651 271,584 419,366 376,789 426,652 372,096 (+23%) Europe and Asia Milestone/Sub- 9
Slide 7: 3Q 2024 Financial Results
3Q 2024 Financial Results NT$(000) 1Q-3Q 2024 1Q-3Q 2023 Amount Change % Change Operating revenue 644,597 580,345 64,252 11% Operating costs 35,271 37,860 (2,589) (7%) Gross profit 609,326 542,485 66,841 12% Sales expenses 28,251 28,650 (399) (1%) G&A expenses 73,673 70,470 3,203 5% R&D expenses 179
Slide 8: ONIVYDE Status & Market Analysis
ONIVYDE® STATUS & MARKET ANALYSIS • Applied for NHI reimbursement in 2Q24 (Taiwan) • ONIVYDE® regimen (NALIRIFOX) for 1L PDAC received sNDA from US FDA, Australia TGA, and Taiwan TFDA, and EU EMA • 2022 global patients with initial diagnose of pancreatic cancer: 510,991 (GLOBOCAN 2022 Data) • 2021 T
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 2024 US FDA, Australia TGA, EU EMA 1996 US FDA approval 2013 TFDA license 2015.3 TFDA license and Taiwan FDA approved sNDA
Slide 10: LIPORAXEL
PharmaEngine RR ERM B LIPORAXEL®
Slide 11: LIPORAXEL is the World's First Oral Paclitaxel
Potential Benefit Compared with Paclitaxel (IV) 1. Administration convenience (at home) 2. Preventive drugs before chemotherapy is not needed LIPORAXEL® 3. Reduce the occurrence of peripheral neuropathy* *Based on phase 3 gastric cancer results is the World’s First Oral Paclitaxel Indication Advance
Slide 12: LIPORAXEL Competitor Comparison
LIPORAXEL® Competitor Comparison Item LIPORAXEL® IV Paclitaxel Abraxane Solvent/Formulation Lipid emulsified formulation Castro oil Taxol-albumin Dexamethasone, promethazine, Pre-medication Not required Not required Cimetidine Admin. Route Oral solution Intravenous injection Intravenous injection 13
Slide 13: 2021 Taiwan Top 10 Cancer: Number of Patients
2021 Taiwan Top 10 Cancer: Number of Patients 16,880 16,238 15,448 10,775 8,211 7,481 4,626 4,060 3,954 3,190 Lungs, bronchi and Large intestine Breast (female) Liver and Oral cavity, Prostate Thyroid Stomach Skin Pancreas trachea intrahepatic bile oropharynx and duct hypopharynx Source: Health Prom
Slide 14: R&D Pipeline
PharmaEngine RR ERM B R&D PIPELINE
Slide 15: 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 PEP07 Hematologic Global (CHK1i) Cancer PEP07 Solid Tumors Global DNA (CHK1i)
Slide 16: 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 17: Vision for 2025
PharmaEngine RR ERM B VISION FOR 2025
Slide 18: Vision for 2025
Complete dose finding for PEP07 phase 1 hematologic and solid 1 tumor cancers 2 File IND for one preclinical candidate (1H25) Cooperate with AI platform partners to expand AI drug discovery 3 portfolio Vision for 2025 Obtain Taiwan’s NHI reimbursement for ONIVYDE® as 1L 4 treatment of metastatic pan
Slide 19: Thank You!
PharmaEngine HeteR ® THANK YOU!