Slide 1: 1Q 2025 Investors' Conference
1Q 2025 INVESTORS’ CONFERENCE 2025/05/06 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. 1Q25 Operational Highlights 2. 1Q25 Operational Overview 3. R&D Pipeline ◆ PEP07 ◆ PEP08 4. Vision for 2025 5. Q&A
Slide 4: 1Q25 Operational Highlights: Sustainable Growth and Enhanced Pipeline
1Q25 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. Applied Taiwan health 1. PEP07 two Phase 1 clinical 1. 1Q25 cash and cash insurance reimburs
Slide 5: 1Q25 Operational Overview
1Q25 OPERATIONAL OVERVIEW
Slide 6: Sales and Royalties Drive Long-term Growth
Sales and Royalties Drive Long-term Growth NT$(000) 1Q25 Items Year 2019 2020 2021 2022 2023 2024 YoY (%) Taiwan Sales 180,389 214,828 235,469 277,594 278,547 279,990 67,844 (+3.9%) Royalties from 133,651 271,584 419,366 376,789 426,652 543,286 119,538 (+20.5%) Europe and Asia Milestone 0 569,600 0
Slide 7: 1Q25 Financial Results
1Q25 Financial Results NT$ (000) 1Q25 1Q24 Amount Change % Change Operating revenue 187,382 164,471 22,911 14% Operating costs 12,384 11,045 1,339 12% Gross profit 174,998 153,426 21,572 14% Sales expenses 7,329 7,152 177 2% G&A expenses 23,406 22,375 1,031 5% R&D expenses 55,474 56,521 (1,047) (2%)
Slide 8: R&D Pipeline
R&D PIPELINE
Slide 9: 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 Milestone Royalty ONIVYDE® (EU/Asia) 1L/2L PDAC Approval (liposomal irinotecan) Taiwan Sales AML/MCL PEP07 Global (CHK1i) Solid tumors DDR & PEP08 MTAP-
Slide 10: PEP07
PEP07
Slide 11: PEP07: A Potential Best in Class CHK1 Inhibitor
PEP07: A Potential Best in Class CHK1 Inhibitor ACR-368 Criterion PEP07 (Prexasertib) SRA-737 BBI-355 Development Phase Phase I Phase II Phase I/II Phase I/II Potency* CHK1 vs CHK2 Selectivity Oral Bioavailability BBB-Penetrating Unknown Endometrial cancer AML/MCL Indications Ovarian cancer Solid tu
Slide 12: PEP07: Potential Indications and Market Value
PEP07: Potential Indications and Market Value Global 2022 Market Size CAGR Potential Indication Cancer type Market Size^ 2023 Incidence* 2024-2032^ ($ Bn) Acute Myeloid Leukemia 165,500 2.1 10.7% Gastric Cancer 968,350 4.7 13.5% High Potential Soft Tissue Sarcoma 42,500 1.4 8.5% GBM 321,476 2.9 8.6%
Slide 13: PEP08
PEP08
Slide 14: PEP08: A Potential Best in Class MTA-cooperative PRMT5 Inhibitor
PEP08: A Potential Best in Class MTA-cooperative PRMT5 Inhibitor BMS-986504 Criterion PEP08 AMG-193 TNG462 AZ3470 (MRTX1719) IND- Development Phase Phase 1/2 Phase 1/2 Phase 1/2 Phase 1/2 enabling Potency* MTAP selectivity BBB-penetrating MTAP-deleted cancers Indication NSCLC, PDAC NSCLC Solid tumor
Slide 15: PEP08: High Selectivity
PEPO8: High Selectivity PEPO8 selectively targets MTAP-deletion cancers and inhibits PRMT5-MTA Complex MTAP-Deletion Tumor Cells (MTA accumulation) Normal Cells So PEPOS No stable binding yo: PRMTS-MTA complex Spared Death
Slide 16: MTAP Deletion Frequency in Selected Tumors and its Market Size
MTAP Deletion Frequency in Selected Tumors and its Market Size % of MTAP Eligible Cancer type Incidence* Deletion Patients No. GBM 321,476 42% 135,020 Bladder 613,791 25% 153,448 Pancreas 510,566 22% 112,325 NSCLC 2,108,000 13% 274,040 ESCC 510,716 10% 51,072 HNSCC 795,453 10% 79,545 Stomach 968,350
Slide 17: PEP08 synergizes with PEP07 in brain tumor animal study
PEP08 synergizes with PEP07 in brain tumor animal study 600 BLI (photons/s*10^6) Vehicle Control 400 PEP07 30 mpk Q2D PE-0260 12.5 mpk QD 200 PEP07 30 mpk Q2D + PEP08 12.5 mpk QD 0 0 10 20 Days on treatment This is our PRMT5 and CHK1 inhibitors in brain tumor orthotopic CDX mouse model. The bio-lumi
Slide 18: Virtual Pharmaceutical Company Business Model
Virtual Pharmaceutical Company Business Model Target Compound Lead Approval/ Validation Screening Optimization Preclinical Phase 1 Phase 2 Phase 3 Market PEP08 PEP07 In-house R&D In-license Partners Out-license (CRO/CDMO/Commercial ) Flexible, nimble, and science/data driven
Slide 19: Vision for 2025
VISION FOR 2025
Slide 20: Vision for 2025
Vision for 2025 1 Complete dose finding for PEP07 phase 1 hematologic cancers and solid tumors 4 Continue to expand and advance early pipeline 2 PEP07 to enter dose expansion of selected indications 5 Obtain Taiwan’s NHI reimbursement for ONIVYDE® as 1L treatment of metastatic pancreatic cancer 3 Su
Slide 21: Thank You
THANK YOU PharmaEngine, Inc.