Slide 1: 1H22 Earning Result
1H22 Earning Result 2022/07/27 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. 1H22 Operational Highlights 2. 1H22 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 in 1H22
Keep Deliver Sustainable Growth and Enhanced Value in 1H22 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:
Slide 5: 1H22 Operational Overview
1H22 Operational Overview ONIVYDE®Revenue with Stable Growth
Slide 6: Sales and Royalties Drives Long-term Growth
Sales and Royalties Drives Long-term Growth NTD $(000) Items Year 2017 2018 2019 2020 2021 1H21/1H22 YoY (%) Taiwan Sales 40,651 87,384 180,389 214,828 235,469 135,399 (20%) Royalties from Europe and Asia 63,526 109,825 133,651 271,584 419,366 205,629 (27%) Milestone 749,500 96,221 0 569,600 0 0 Tot
Slide 7: 1H22 Financial Results
1H22 Financial Results NTD$ (000) 2022H1 2021H1 Amount Change % Change Operating revenue 341,028 273,908 67,120 25 Operating costs 23,948 19,238 4,710 24 Gross profit 317,080 254,670 62,410 25 Sales expenses 15,807 15,501 306 2 G&A expenses 45,405 39,944 5,461 14 R&D expenses 42,024 70,519 (28,495)
Slide 8: Research and Development
Research and Development ONIVYDE® 2L SCLC Phase III Readout at 2H22 PEP07 (SOL-578) File IND at 2H22 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 LCM: Life cycle management; PDAC: Pancreatic ductal adenocarcinoma; SCLC: Small cell lung cancer; DoT: Duration of treatment; 1L: First line; 2L: Second line; 1. 10 IQVIA APLD claims, September 2020 ; 2. Expected submission dates ; 3. Risk adjust
Slide 11: Small Cell Lung Cancer (SCLC)
Small Cell Lung Cancer (SCLC) Characteristics of SCLC2 • Rapid doubling time • High growth fraction • Paraneoplastic syndromes • Early development of widespread metastases • SCLC is a very aggressive cancer that is usually diagnosed at the extensive stage3 • 5yr survival • Limited stage ranges from
Slide 12: SCLC New Drug Development with High Entry Barrier
SCLC New Drug Development with High Entry Barrier
Slide 13: 2L SCLC Treatment is Urgent Unmet Medical Need
2L SCLC Treatment is Urgent Unmet Medical Need Extensive Stage, 1L Limited Stage, 1L 2L+ Platinum + Lurbinectedin (2021) FDA Approved Etoposide Topotecan (2007) + Atezolizumab or Durvalumab Platinum Cisplatin Relapse ≤ 6 months: + + NCCN Guideline topotecan Etoposide Etoposide Preferred regimens or
Slide 14: 2L SCLC U.S. Market Opportunity
2L SCLC U.S. Market Opportunity 抗化藥性 非抗化藥性 1 Jazz market research, SHS claims data; Other sources: SEER Cancer Stat Facts https://seer.cancer.gov/statfacts/html/lungb.html, accessed April 19, 2019; American Cancer Society, https://www.cancer.org/cancer/small cell lung cancer/about/what is small cell
Slide 15: Estimated major-market sales of key therapies for small-cell lung cancer
Estimated major-market sales of key therapies for small-cell lung cancer, by drug class The figure shows the 2018–2028 forecast for the seven major markets: the USA , France, Germany , Italy , Spain, UK and Japan. CDK4/6, cyclin- dependent kinase 4/6. Source: Jazz market research. Other treatments i
Slide 16: ONIVYDE: Potential to Establish Standard of Care in 2L SCLC
ONIVYDE® : Potential to Establish Standard of Care in 2L SCLC SCLC: small cell lung cancer; ORR: Overall response rate; DCR: Disease control rate; RECIST: Response evaluation criteria in solid tumors; PFS: Progression free survival; ECOG: Eastern cooperative oncology group functional status measure;
Slide 17: PEP07 (SOL-578)
PEP07 (SOL-578) Early-stage DDR Project Transactions Became Hotter Keep Moving Forward to Phase I IND
Slide 18: DNA Damage Repair: One Critical Pathway, Multiple Targets
DNA Damage Repair One Critical Pathway, Multiple Targets DDR deal transactions became hotter Pipeline Date. Biotech Pharma Target Deal Size Stage • Upfront: $65M Undisclosed x 2020.05.26 Repare BMS Discovery • Milestone: $3.0bn 10 • Royalties: high SD - Low DD • Upfront: $20M 2021.04.07 Artios Novar
Slide 19: PEP07 (SOL-578) – Potential Best in Class CHK1 Inhibitor
PEP07 (SOL-578) – Potential Best in Class CHK1 Inhibitor PEP07 (SOL-578) is a brain penetrating oral inhibitor which is more potent, selective, specific than the competitors. 19
Slide 20: PEP07 (SOL-578): Significant Efficacy in Hematologic Malignancies
PEP07 (SOL-578) : Significant Efficacy in Hematologic Malignancies as Monotherapy and Combination Therapy Acute Myeloid Leukemic (AML) Ara-C Sensitive Ara-C Resistant THP-1 tumor size 1500 Vehicle 2-on/5-off x 4 cycles Vehicle 2500 10 ml/kg BID (3on/4off)x4 PO (mm^3) Tumor Volume (mm3) Vehicle Vehic
Slide 21: PEP07 Combined with Radiation Shows Tumor Reduction in Medulloblastoma 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 22: PEP07 (SOL-578) for Potential Combination Therapies
PEP07 (SOL-578) 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: Synerg
Slide 23: PEP07 (SOL-578) Keep Moving Forward to Phase I
PEP07 (SOL-578) Keep Moving Forward to Phase I 2021 2022 Development Plan 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 Preclinical Development CMC Development Toxicology Development IND Preparation/ Submission Preclinical CMC Additional Efficacy studies in animal models ongoing 1 kg of GMP
Slide 24: Vision for 2022
Vision for 2022
Slide 25: Virtual Pharmaceutical Company Business Model
Virtual Pharmaceutical Company Business Model COMPUTATIONAL 25
Slide 26: Pipeline Portfolio Focus on Precision Oncology
Pipeline Portfolio Focus on Precision Oncology 26
Slide 27: 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. 2L SCLC Phase III data readout 3. 1L PDAC Phase III data readout (2023) Advancement and growth of early-stage pipeline 1. PEP07 IND/CTA
Slide 28: PharmaEngine
PharmaEngine ee tk QB