PharmaEngine (智擎生技製藥) 3Q 2025 Institutional Investor Conference
Date: 2025/11/03
Presenter: 張麒星 (Chi-Hsing Chang), Vice President & Spokesperson
Company Overview
- Company Name: PharmaEngine (智擎生技製藥)
- Stock Code: 4162.TWO
- Mission: Focuses on precision oncology.
Disclaimer
- This presentation contains forward-looking information based on information obtained from internal and external sources.
- Actual future operating results, financial status, and business outcomes may differ from these statements due to various factors, including market risks and ongoing new drug projects.
- The future outlook reflects the company's current views, which will be updated as changes occur.
Financial Highlights and Key Metrics (1Q-3Q 2025)
- Cash and Financial Assets (as of 3Q25 end): NT$4.591 billion.
- Green Energy Usage (2025): Green electricity accounts for 20% of self-used electricity.
ONIVYDE® Revenue Trends (NT$ Thousand)
| Item | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 1Q-3Q 2025 | 1Q-3Q 2025 vs 1Q-3Q 2024 YOY (%) |
|---|---|---|---|---|---|---|---|---|
| Taiwan Sales Revenue | 180,389 | 214,828 | 235,469 | 277,594 | 278,547 | 279,990 | 197,200 | -7% |
| Europe/Asia Sales Royalty Income | 133,651 | 271,584 | 419,366 | 376,789 | 426,652 | 543,286 | 422,609 | +14% |
| Milestone/License Income | 0 | 569,600 | 0 | 0 | 62,470 | 1,700,028 | 6,521 | -89% |
| Total | 314,040 | 1,056,012 | 654,835 | 654,383 | 767,669 | 2,523,304 | 626,330 | -3% |
3Q 2025 Operational Overview (Unit: NT$ Thousand)
| Item | 1Q-3Q 2025 | 1Q-3Q 2024 | Amount Change | % Change |
|---|---|---|---|---|
| Operating Revenue | 626,330 | 644,597 | (18,267) | (3%) |
| Operating Cost | 35,829 | 35,271 | 558 | 2% |
| Gross Profit | 590,501 | 609,326 | (18,825) | (3%) |
| Selling Expenses | 22,359 | 28,251 | (5,892) | (21%) |
| Administrative Expenses | 71,310 | 73,673 | (2,363) | (3%) |
| R&D Expenses | 190,331 | 179,817 | 10,514 | 6% |
| Operating Expenses | 284,000 | 281,741 | 2,259 | 1% |
| Operating Income | 306,501 | 327,585 | (21,084) | (6%) |
| Non-operating Income (Expenses) | 35,510 | 63,270 | (27,760) | (44%) |
| Profit Before Tax | 342,011 | 390,855 | (48,844) | (12%) |
| Income Tax Expense | 85,461 | 58,090 | 27,371 | 47% |
| Net Profit for the Period | 256,550 | 332,765 | (76,215) | (23%) |
| Basic EPS (NT$) | 1.79 | 2.32 | (0.53) | (23%) |
Recent Performance and Results (3Q 2025 Operational Highlights)
Market Side
- ONIVYDE® (安能得®) New Indication Application:
- The application for ONIVYDE® combination therapy to be included in health insurance reimbursement for first-line metastatic pancreatic cancer treatment is expected to have results announced by the end of 2025.
R&D Side
- New Product R&D Progress Accelerates:
- PEP07: Phase I clinical trial expected to complete maximum tolerated dose confirmation by the end of 2025, entering the expansion phase.
- PEP08: First patient in the Phase I clinical trial was dosed in October 2025.
- PEP09 & PEP10: R&D progress meets expectations in collaboration with external new drug R&D platforms.
Operations Side
- Company Operations Stable Growth:
- As of the end of 3Q25, cash and cash equivalents and financial assets reached NT$4.591 billion.
- Green electricity accounts for 20% of self-used electricity in 2025.
Products, Services & Technology
Product Portfolio Focuses on Precision Oncology
| Program | Indications | Lead | Preclinical | Phase I | Phase II | Phase III | Approval | Commercial Rights | Partner |
|---|---|---|---|---|---|---|---|---|---|
| ONIVYDE® (liposomal irinotecan) | 1L/2L PDAC | Approval | Milestone Royalty (EU/Asia) | IPSEN | |||||
| Taiwan Sales | |||||||||
| PEP07 (CHK1i) | AML/MCL | Global | Sentinel ONCOLOGY | ||||||
| Solid tumors | |||||||||
| PEP08 (PRMT5i) | MTAP-del cancers | Global | PEI Owned | ||||||
| PEP09 | Undisclosed | Global | Undisclosed | ||||||
| PEP10 | Undisclosed | Global | PEI Owned |
PEP07 (CHK1 Inhibitor)
- Mechanism: CHK1 is critical for cell cycle regulation and DNA damage repair. PEP07 inhibits CHK1 function, leading to cell apoptosis if repair issues occur.
- Comparison with other Oral CHK1 Inhibitors:
| Criterion | PEP07 | ACR-368 (Prexasertib) | SRA-737 | BBI-355 |
|---|---|---|---|---|
| Development Phase | Phase I | Phase II | Phase I/II | Phase I/II |
| Potency* | Excellent | Excellent | Good | Excellent |
| CHK1 vs CHK2 Selectivity | Excellent | Poor | Excellent | Good |
| Oral Bioavailability | Excellent | Poor | Excellent | Excellent |
| BBB-Penetrating | Excellent | Excellent | Unknown | Poor |
| Indications | AML/MCL, Solid tumors | Endometrial cancer, Ovarian cancer, Bladder cancer | Solid tumors | Solid tumors |
(Cell line model)
-
Phase I Clinical Trial Plan:
- Hematologic Cancers Arm: Dose escalation → Dose expansion in AML and MCL → Phase I Combo targeting AML and MCL.
- Solid Tumors Arm: Dose escalation → Dose expansion → Phase I Combo targeting selected indications.
-
Potential Indications and Patient Numbers (2022 Incidence):
- AML: 165,500
- MCL: 33,323
- Gastric Cancer: 968,350
- Soft Tissue Sarcoma: 42,500
- Glioblastoma Multiforme (GBM): 321,476
- Small Cell Lung Cancer (SCLC): 372,100
- Ovarian Cancer: 324,398
- Total: 2,194,324
-
Potential Market Size:
- AML: Projected Global Market Size: US$2.1 Billion (2023) to US$5.1 Billion (2032). CAGR (2024-2032) = 10.7%.
- MCL: Projected Global Market Size: US$2.53 Billion (2024) to US$3.97 Billion (2030). CAGR (2024-2030) = 7.8%.
(Source: Global Insight Markets, Verified Market Reports, Research and Markets, Growth Market Reports)
PEP08 (Second-Generation MTA-Cooperative PRMT5 Inhibitor)
- Mechanism of Action: Synthetic Lethality: MTAP-deleted cancer cells depend on PRMT5 function. PEP08 inhibits PRMT5, leading to tumor cell death while sparing normal cells.
- Comparison with other MTA-Cooperative PRMT5 Inhibitors:
| Criterion | PEP08 | AMG-193 (AMGEN) | BMS-986504 (MRTX1719) | TNG462 (Tango) | AZ3470 (Astra Zeneca) |
|---|---|---|---|---|---|
| Development Phase | Phase I | Phase II | Phase I/II | Phase I/II | Phase I/II |
| Potency* | Excellent | Good | Excellent | Excellent | Excellent |
| MTAP selectivity | Excellent | Excellent | Excellent | Good | Good |
| BBB-penetrating | Excellent | Excellent | Poor | Poor | Poor |
| Indication (MTAP-deleted cancers) | Solid tumors | NSCLC | NSCLC, PDAC, Mesothelioma | NSCLC, PDAC | Solid tumors, r/r cHL |
(Viability in vitro in MTAP del cell line model)
-
Efficacy in Animal Models: PEP08 shows significant efficacy in animal models of MTAP gene-deleted solid tumors.
-
Combination Therapy: PEP07+PEP08 shows significant synergistic effects in pancreatic cancer and GBM models.
-
Potential Market, Indications, and Patient Numbers:
- PRMT5 Inhibitor Market: Projected Global Market: US$0.312 Billion (2024) to US$2.08 Billion (2033). CAGR (2024-2033) = 23.7%.
- Patients with Specific MTAP Gene Deletion Indications (2022):
- GBM: 135,020
- Bladder: 153,448
- Pancreas: 112,325
- DLBCL: 29,032
- NSCLC: 274,040
- ESCC: 51,072
- HNSCC: 79,545
- Stomach: 77,468
- Total: 911,950
(Source: Research Intelo, Globocan 2022)
Future Outlook and Guidance (2026 Operational Outlook)
- Strategic Initiatives and Plans:
- Actively conduct PEP07 Phase I combination therapy clinical trials.
- Continue to advance patient enrollment for PEP08 Phase I human clinical trials.
- Complete nomination of drug candidates.
- Collaborate with AI/CADD platform partners for DDR or synthetic lethality drugs.
- Green Energy Goal: Convert 30% of operational electricity sources to green energy by 2026, increasing 10% annually to reach 70% by 2030.