PharmaEngine (智擎生技) [4162.TWO] 1H 2025 法說會簡報

Company Overview

• Company Name: PharmaEngine (智擎生技製藥)
• Core Focus: Product portfolio focused on precision oncology.
• Business Segments (as per 1H25 Operational Highlights):
  • Market Side (市場端): Progress of ONIVYDE® new indications.
  • R&D Side (研發端): Acceleration of new product R&D progress.
  • Operations Side (營運端): Stable company operational growth.

Financial Highlights and Key Metrics (1H 2025)

1.1. Cash and Financial Assets (as of June 30, 2025)

• Cash and cash equivalents and financial assets measured at amortized cost (time deposits over three months): Approximately NT$5.4 billion.

1.2. 1H 2025 Financial Performance (NT$’000)

Recent Performance and Results (1H 2025)

2.1. ONIVYDE® Revenue Trend (NT$’000)

2.2. Green Energy Adoption

• Green energy substitution rate from January to June 2025: 20%.

Future Outlook and Guidance (2025 Operational Outlook)

• Key Goals for 2025:
  1. Confirm the maximum tolerated dose for PEP07 Phase I blood and solid tumor clinical trials.
  2. PEP07 selects indications and enters dose expansion.
  3. Submit PEP08 IND application (1H25).
  4. Continue to expand and advance the R&D product portfolio.
  5. Obtain ONIVYDE® first-line pancreatic cancer National Health Insurance (NHI) reimbursement price in Taiwan.
  6. Starting in 2025, convert 20% of operational electricity sources to green energy, with an annual increase of 10% in green energy usage, aiming to reach 70% of operational electricity from green energy by 2030.

Strategic Initiatives and Plans

• Market Strategy:
  • For ONIVYDE®, pursuing Taiwan NHI reimbursement for first-line pancreatic cancer, with an application submitted in Q2 2024 and currently under negotiation.
• R&D Acceleration:
  • Continuing PEP07 Phase I blood and solid tumor trials.
  • PEP08 Phase I solid tumor human clinical trial passed Australian HREC review and TGA re-examination.
  • Advancing several early-stage R&D projects.
• Environmental, Social, and Governance (ESG) Initiative:
  • Commitment to transition to green energy for operational electricity, starting with 20% in 2025 and increasing by 10% annually to reach 70% by 2030.

Key Charts, Graphs, and Data Points

5.1. Projected Global Market Size for AML (Acute Myeloid Leukemia)

• 2023: US$2.1 billion
• 2032: US$5.1 billion
• CAGR (2024-2032): 10.7%
• Current Target Therapy Drugs for AML (Venetoclax):
  • Current Market Size (2024): US$300 million
  • Projected Market Size (2033): US$1.2 billion
  • CAGR (2026-2033): 17.5%
  • Source: Global Insight Markets, Verified Market Reports

5.2. Projected Global Market Size for MCL (Mantle Cell Lymphoma)

• 2024: US$2.53 billion
• 2030: US$3.97 billion
• CAGR (2024-2030): 7.8%
• Current Target Therapy Drugs for MCL (BTK Inhibitors):
  • Acalabrutinib:
    • Current Market Size (2024): US$1.2 billion
    • Projected Market Size (2033): US$2.5 billion
    • CAGR (2026-2033): 9.1%
  • Pirtobrutinib:
    • Current Market Size (2024): US$312 million
    • Projected Market Size (2033): US$2.057 billion
    • CAGR: 24.7%
  • Source: Research and Markets, Verified Market Reports, Growth Market Reports

5.3. Projected Global Market Size for GBM (Glioblastoma Multiforme)

• 2024: US$3.6 billion
• 2034: US$8.3 billion
• CAGR (2025-2034): 8.9%
• Current Target Therapy Drugs for GBM (Temozolomide (TMZ)):
  • Current Market Size (2023): US$924 million
  • Projected Market Size (2032): US$1.179 billion
  • CAGR: 3.1%
  • Source: Global Insight Markets, Intellectual Market Insights Research

Products, Services & Technology

6.1. Product Portfolio Focused on Precision Oncology

• ONIVYDE® (liposomal irinotecan)

  • Indications: 1L/2L PDAC (Pancreatic Ductal Adenocarcinoma)
  • Development Phase: Approved
  • Commercial Rights: Milestone Royalty (EU/Asia), Taiwan Sales
  • Partner: IPSEN

• PEP07 (CHK1i - CHK1 Inhibitor)

  • Indications: AML/MCL (Acute Myeloid Leukemia/Mantle Cell Lymphoma), Solid tumors
  • Development Phase: Phase I
  • Commercial Rights: Global
  • Partner: Sentinel ONCOLOGY
  • Mechanism of Action: CHK1 inhibits cell DNA repair, preventing replication and causing cell apoptosis.
  • Key Features:
    • Potency: Excellent
    • CHK1 vs CHK2 Selectivity: Excellent
    • Oral Bioavailability: Excellent
    • BBB-Penetrating: Excellent
  • Potential Indications:
    • Total eligible patients: 2,194,324

• PEP08 (Second-generation PRMT5i - PRMT5 Inhibitor)

  • Indications: MTAP-del cancers
  • Development Phase: Phase I
  • Commercial Rights: Global
  • Partner: PEI Owned
  • Mechanism of Action: Targets MTAP-deficient cancer cells.
  • Key Features:
    • Potency: Excellent
    • MTAP selectivity: Excellent
    • BBB-penetrating: Excellent
  • Potential Indications: Total Eligible Patients: 911,950

• PEP09

  • Indications: Undisclosed
  • Development Phase: Phase I
  • Commercial Rights: Global
  • Partner: Undisclosed

• PEP10

  • Indications: Undisclosed
  • Development Phase: Phase I
  • Commercial Rights: Global
  • Partner: PEI Owned

6.2. Industry-Specific Terminology and Technical Concepts

• CHK1: A protein kinase crucial for cell cycle checkpoints and DNA damage repair.
• PRMT5: An enzyme involved in cellular processes, including gene expression.
• MTA: A byproduct of polyamine synthesis in certain cancer cells.
• MTAP-del: A genetic deletion leading to MTAP deficiency in cancers.
• Synthetic Lethality: A genetic interaction that leads to cell death under specific conditions.
• BBB-Penetrating: The ability of a drug to cross the blood-brain barrier.
• AML: Acute Myeloid Leukemia, a type of blood and bone marrow cancer.
• MCL: Mantle Cell Lymphoma, a rare aggressive type of non-Hodgkin lymphoma.
• GBM: Glioblastoma Multiforme, an aggressive brain cancer.
• PDAC: Pancreatic Ductal Adenocarcinoma, the most common pancreatic cancer type.
• NSCLC: Non-Small Cell Lung Cancer, a type of lung cancer.
• ESCC: Esophageal Squamous Cell Carcinoma, a type of esophageal cancer.
• HNSCC: Head and Neck Squamous Cell Carcinoma, starting in the head and neck region.
• DLBCL: Diffuse Large B-cell Lymphoma, a form of non-Hodgkin lymphoma.
• r/r cHL: Relapsed/Refractory Classical Hodgkin Lymphoma.
• IND: Investigational New Drug application for testing in humans.
• HREC: Independent committee reviewing research to ensure ethical standards.
• TGA: Australia’s therapeutic goods regulatory body.
• NHI: Taiwan's national healthcare system.