Slide 1: 2022 YTD Earning Result
2022 YTD Earning Result 2022/10/28 Chi-Hsing Chang, VP Andy Tung, IR
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. 2022 YTD Operational Highlights 2. 2022 YTD Operational Overview 3. Research and Development ONIVYDE® PEP07 (SOL-578) 4. Vision for 2022 5. Q&A
Slide 4: Keep Deliver Sustainable Growth and Enhanced Value
Keep Deliver Sustainable Growth and Enhanced Value Commercial Pipeline Operation ONIVYDE ® market and new indication expansion New project licensing and RD progress Operation with a sustainable growth 1. ONIVYDE® 2L PDAC treatment got China NMPA accelerated 1. 1Q22 Cash and cash equivalents: approve
Slide 5: 2022 YTD Operational Overview
2022 YTD Operational Overview ONIVYDE® Sales Unit with Stable Growth
Slide 6: Sales and Royalties Drives Long-term Growth
Sales and Royalties Drives Long-term Growth NTD $(000) 2021 YTD/ 2022 YTD Items Year 2017 2018 2019 2020 2021 YoY (%) Taiwan Sales 40,651 87,384 180,389 214,828 235,469 211,942 (22.5%) Royalties from Europe and Asia 63,526 109,825 133,651 271,584 419,366 283,968 (2.2%) Milestone 749,500 96,221 0 569
Slide 7: 2022 YTD Financial Results
2022 YTD Financial Results NTD$ (000) 2022 YTD 2021 YTD Amount Change % Change Operating revenue 495,910 451,034 44,876 10% Operating costs 37,416 29,472 7,944 27% Gross profit 458,494 421,562 36,932 9% Sales expenses 29,111 23,765 5,346 22% G&A expenses 74,226 62,820 11,406 18% R&D expenses 122,037
Slide 8: Research and Development
Research and Development • ONIVYDE® 1L PDAC Phase III Readout at YE22 • PEP07 File IND at YE22 • PEP07 Officially Licensing in from Sentinel Oncology • Multiple Projects Under Evaluation with External AI/CADD collaboration
Slide 9: ONIVYDE Keep Global Market Expansion at 2L PDAC
ONIVYDE® Keep Global Market Expansion at 2L PDAC Approved Yet approved 9
Slide 10: ONIVYDE LCM: Expansion into New Tumor Types Globally
ONIVYDE® LCM: Expansion into New Tumor Types Globally 10
Slide 11: ONIVYDE: 1L pancreatic ductal adenocarcinoma (PDAC)
ONIVYDE®: 1L pancreatic ductal adenocarcinoma (PDAC) 暫定文字可自訂義編輯 PDAC: Pancreatic ductal adenocarcinoma; ORR: Overall response rate; DCR: Disease control rate; DOR: Duration of response; PFS: Progression free survival; OS: Overall survival; RECIST: Response evaluation criteria in solid tumors; ECOG:
Slide 12: Frontline Regimens for Patients With Metastatic Pancreatic Cancer
Frontline Regimens for Patients With Metastatic Pancreatic Cancer FOLFIRINOX vs Gem nab-Pac + Gem vs Gem Trial Characteristics and Outcomes (N = 342)[1] (N = 861)[2] Median age, yrs (range) 61 (25-76) 62 (27-86) Male, % 62 57 Region (NA/WE/EE/A), % 0/100 (France)/0/0 62/9/15/14 ECOG PS/KPS (0/100, 1
Slide 13: Metastatic Pancreatic Cancer Treatment Market Analysis (I)
Metastatic Pancreatic Cancer Treatment Market Analysis (I) Metastatic Pancreatic Cancer 1st line 95% -> 80% 5% -> 20% 2nd line 65% -> 55% 5% -> 15% 3rd line 5% -> 10% 13
Slide 14: Metastatic Pancreatic Cancer Treatment Market Analysis (II)
Metastatic Pancreatic Cancer Treatment Market Analysis (II) Metastatic Pancreatic Cancer 11 st line st line NALIRIFOX / FOLFIRINOX 95% -> 80% -> 40% 5% -> 20% -> 60% 2nd line 65% -> 55% -> 30% 5% -> 15% -> 45% 3rd line 5% -> 10% -> 30% 14
Slide 15: PEP07 (CHK1 inhibitor)
PEP07 (CHK1 inhibitor) • PEP07 Officially Licensing in from Sentinel Oncology • Early-stage DDR Project Transactions Became Hotter • Keep Moving Forward to Phase I IND
Slide 16: DNA Damage Repair: One Critical Pathway, Multiple Targets
DNA Damage Repair One Critical Pathway, Multiple Targets DDR deal transactions became hotter Pipeline Date. Licensor Licensee Target Deal Size Stage • Upfront: $65M Undisclosed x 2020.05.26 Repare BMS Discovery • Milestone: $3.0bn 10 • Royalties: high SD - Low DD Undisclosed x • Upfront: $20M 2021.0
Slide 17: 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, selective, specific than the competitors. 17
Slide 18: PEP07: Significant Efficacy in Hematologic Malignancies
PEP07 : Significant Efficacy in Hematologic Malignancies as Monotherapy and Combination Therapy Acute Myeloid Leukemic (AML) Ara-C Sensitive Ara-C Resistant 1500 Vehicle 2-on/5-off x 4 cycles 2500 Tumor Volume (mm3) Vehicle Tumor Volume (mm3) 2000 Ara-C 50 mpk 5-on/2-off 1000 1500 PEP07 50mpk 2on/5-
Slide 19: PEP07 Combined with Radiation in Medulloblastoma Orthotopic Model
PEP07 (p.o.) Combined with Radiation Shows Tumor Reduction and Survival Benefit in Medulloblastoma Orthotopic Model PEP07 (p.o.) + CSI increase tumor free survival PEP07 (p.o.) + CSI show Intracranial tumors regression PEP07 + CSI PEP07 is a potent brain penetrating oral inhibitor which has potentia
Slide 20: 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 21: PEP07 Early-Stage Clinical Development Strategy
PEP07 Early-Stage Clinical Development Strategy P1b Combo, dose escalation/expansion in AML P1b monotherapy, dose escalation/expansion in AML, P1b Combo, dose escalation/expansion in MCL MCL, and advanced or metastatic solid tumor P1b Combo, dose escalation/expansion in selected solid tumors Preclin
Slide 22: PEP07 Keep Moving Forward to Phase I
PEP07 Keep Moving Forward to Phase I 22
Slide 23: Vision for 2022
Vision for 2022
Slide 24: Virtual Pharmaceutical Company Business Model
Virtual Pharmaceutical Company Business Model COMPUTATIONAL 24
Slide 25: Pipeline Portfolio Focus on Precision Oncology
Pipeline Portfolio Focus on Precision Oncology 25
Slide 26: 2022: Year of Revitalization and Marching Forward
2022: Year of Revitalization and Marching Forward Growth through ONIVYDE® life cycle management 1. 2L PDAC get approval and reimbursement in additional countries 2. 1L PDAC Phase III data readout (YE22) Advancement and growth of early-stage pipeline 1. PEP07 IND/CTA submission 2. Co-develop 2nd DDR
Slide 27: PharmaEngine
PharmaEngine #2 4k RR