PharmaEngine (4162.TWO) 2024 Q3 法人座談會
Company Overview
PharmaEngine 智擎生技製藥 is a company listed on the stock exchange with code 4162.TWO. The presentation title is 智擎生技 4162.TWO 3Q 2024 法人座談會, and it was presented on 2024/11/05 by 張麒星 副總暨發言人 (Chang, Chi-Hsing, Vice President & Spokesperson).
Disclaimer
This presentation contains forward-looking information, including operational outlook, financial status, and business forecasts. The company's actual future operating results, financial status, and business performance may differ from these explicit or implicit forward-looking statements.
Financial Highlights and Key Metrics (1Q-3Q 2024 vs. 1Q-3Q 2023)
The following table summarizes the financial highlights and key metrics:
| 項目 (Item) | 1Q-3Q 2024 (NT$ Thousand) | 1Q-3Q 2023 (NT$ Thousand) | Amount Change (NT$ Thousand) | % Change |
|---|---|---|---|---|
| 營業收入 (Operating Revenue) | 644,597 | 580,345 | 64,252 | 11% |
| 營業成本 (Operating Cost) | 35,271 | 37,860 | (2,589) | (7%) |
| 營業毛利 (Gross Profit) | 609,326 | 542,485 | 66,841 | 12% |
| 推銷費用 (Selling Expenses) | 28,251 | 28,650 | (399) | (1%) |
| 管理費用 (Administrative Expenses) | 73,673 | 70,470 | 3,203 | 5% |
| 研究發展費用 (R&D Expenses) | 179,817 | 231,346 | (51,529) | (22%) |
| 營業費用 (Operating Expenses) | 281,741 | 330,466 | (48,725) | (15%) |
| 營業利益 (Operating Income) | 327,585 | 212,019 | 115,566 | 55% |
| 營業外收入(支出) (Non-operating Income (Expenses)) | 63,270 | 65,709 | (2,439) | (4%) |
| 稅前淨利 (Profit Before Tax) | 390,855 | 277,728 | 113,127 | 41% |
| 所得稅費用 (Income Tax Expense) | 58,090 | 40,451 | 17,639 | 44% |
| 本期淨利 (Net Income) | 332,765 | 237,277 | 95,488 | 40% |
| 基本每股盈餘(元) (Basic EPS (NT$)) | 2.32 | 1.65 | 0.67 | 41% |
Recent Performance and Results (3Q 2024 Operational Highlights)
- Market Side:
- ONIVYDE® New Indication Application:
- In 2024, ONIVYDE® successively obtained marketing approval for new indications from the US FDA, Australia TGA, Taiwan FDA, and EU EMA.
- Applied for National Health Insurance (NHI) reimbursement in Taiwan in 2Q 2024.
- LIPORAXEL®:
- Signed a distribution agreement with Shanghai Nuomai Pharmaceutical Technology in November 2024.
- ONIVYDE® New Indication Application:
- R&D Side:
- New Product R&D Progress Gradually Accelerating:
- Continuously conducting PEP07 Phase I clinical trials for hematologic cancers.
- Continuously conducting PEP07 Phase I clinical trials for solid tumors.
- Collaborating with external new drug R&D platforms on several early-stage R&D projects, with R&D progress in line with expectations.
- New Product R&D Progress Gradually Accelerating:
- Operations Side:
- Company Operations Stable Growth:
- As of 3Q24, cash and cash equivalents, along with financial assets measured at amortized cost (time deposits over three months), reached NT$3.74 billion.
- Completed the first phase of Scope 3 greenhouse gas inventory; data will be disclosed in the 2024 Sustainability Report.
- Company Operations Stable Growth:
ONIVYDE® Revenue Trends (NT$ Thousand)
The following table summarizes the ONIVYDE® revenue trends:
| 項目 (Item) | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 3Q 2024 | 3Q 2024/3Q 2023 YOY (%) |
|---|---|---|---|---|---|---|---|---|
| 台灣銷售收入 (Taiwan Sales Revenue) | 87,384 | 180,389 | 214,828 | 235,469 | 277,594 | 278,547 | 211,723 | -2% |
| 歐亞銷售權利金收入 (Europe & Asia Royalty Income) | 109,825 | 133,651 | 271,584 | 419,366 | 376,789 | 426,652 | 372,096 | +23% |
| 里程碑金/授權金收入 (Milestone/License Income) | 96,221 | 0 | 569,600 | 0 | 0 | 62,470 | 60,778 | -3% |
| 合計 (Total) | 293,430 | 314,040 | 1,056,012 | 654,835 | 654,383 | 767,669 | 644,597 | +11% |
Future Outlook and Guidance (2025 Operational Outlook)
- Confirm the maximum tolerated dose for PEP07 Phase I hematologic and solid tumor clinical trials.
- Advance one pipeline product to the Investigational New Drug (IND)-ready stage (1H25).
- Continue drug development with AI companies to expand the R&D product portfolio.
- Obtain National Health Insurance (NHI) reimbursement price for ONIVYDE® first-line pancreatic cancer.
- Apply for LIPORAXEL® new drug approval in Taiwan.
- Start converting 20% of operational electricity to green energy in 2025, with an annual increase of 10% in green electricity usage, aiming to reach 70% of operational electricity from green sources by 2030.
Strategic Initiatives and Plans
- Market Expansion:
- ONIVYDE®: New indication approvals in US FDA, Australia TGA, Taiwan FDA, EU EMA in 2024. Applied for NHI reimbursement in Taiwan for new indications in 2Q 2024.
- LIPORAXEL®: Signed distribution agreement with Shanghai Nuomai Pharmaceutical Technology in November 2024. Approved in South Korea (2016) and mainland China (2024) for gastric cancer. Phase III trials for breast cancer ongoing in South Korea, mainland China, and Eastern Europe.
- R&D Acceleration:
- PEP07 Phase I trials for hematologic and solid tumors are ongoing.
- Collaboration with external new drug R&D platforms for early-stage projects.
- Focus on advancing pipeline products to IND-ready stage.
- Leveraging AI for drug development to expand the R&D portfolio.
- Sustainability:
- Completed Scope 3 greenhouse gas inventory for 2024.
- Targeting 70% green energy for operations by 2030, starting with 20% in 2025 and increasing 10% annually.
Products, Services & Technology
- Product Portfolio Focus: Cancer Precision Medicine (癌症精準醫療)
- Product Names, Model Numbers, and Technical Specifications:
- ONIVYDE® (liposomal irinotecan)
- Indications: 2L PDAC (Second-line Pancreatic Ductal Adenocarcinoma), 1L PDAC (First-line Pancreatic Ductal Adenocarcinoma).
- Commercial Rights: EU/Asia (Partner: IPSEN Innovation for patient care).
- Taiwan Progress (Pancreatic Cancer Treatment):
- 2L ONIVYDE®: 2015.10 US FDA approval, 2016.4 TFDA license, 2018.8 NHI reimbursed.
- 1L ONIVYDE®: 2024 US FDA, Australia TGA, EU EMA and Taiwan FDA approved SNDA, 2Q24 Applied for NHI reimbursement.
- LIPORAXEL®
- Description: World's first successfully approved oral paclitaxel formulation (紫杉醇口服製劑).
- Potential Advantages over IV Paclitaxel:
- Convenience of use (outside hospital).
- No need for pre-medication before chemotherapy.
- Reduced incidence of peripheral neuropathy (data based on Phase III clinical trials for gastric cancer).
- Competitor Comparison:
- Solvent/Formulation: Lipid emulsified formulation.
- Pre-medication: Not required.
- Route: Oral solution (口服溶液).
- Dose: 400 mg/m².
- Dosing Frequency: Day 1, 8, 15.
- Injection Time: N/A.
- Indications:
- Advanced, metastatic or recurrent gastric cancer (晚期、轉移性或局部復發性胃癌): Approved in South Korea (September 2016) and mainland China (September 2024).
- Metastatic or recurrent breast cancer (轉移性或局部復發性乳癌): Phase III clinical trials ongoing in South Korea, mainland China, and Eastern Europe.
- PEP07 (CHK1i)
- Indications: Hematologic Cancer (血液腫瘤), Solid Tumors (實體腫瘤).
- Development Stage: Phase I (first patient dosed in 2023/08 for hematologic cancers, 2024/04 for solid tumors).
- Clinical Trial Design: Ph1b Mono (dose escalation/expansion) -> Ph1b Combo (dose finding/expansion in selected cancers, e.g., AML or MCL for hematologic cancers).
- Commercial Rights: Global (Partner: Sentinel ONCOLOGY).
- Note: Preclinical biomarker study is ongoing for further design of clinical trials.
- PEP08
- Indications: Undisclosed (Predictive Biomarker).
- Development Stage: Preclinical/Early Phase I.
- Commercial Rights: Global (PEI Owned).
- PEP09
- Indications: Undisclosed.
- Development Stage: Preclinical/Early Phase I.
- Commercial Rights: Global (Undisclosed Partner).
- PEP10
- Indications: Undisclosed (Predictive Biomarker).
- Development Stage: Preclinical/Early Phase I.
- Commercial Rights: Global (PEI Owned).
- ONIVYDE® (liposomal irinotecan)
- Technology Platforms: DNA Damage Response (DDR) & Precision Oncology.
- Industry-specific Terminology and Technical Concepts:
- FDA: U.S. Food and Drug Administration.
- TGA: Therapeutic Goods Administration (Australia).
- EMA: European Medicines Agency.
- TFDA: Taiwan Food and Drug Administration.
- NHI: National Health Insurance (Taiwan).
- SNDA: Supplemental New Drug Application.
- IND: Investigational New Drug.
- PDAC: Pancreatic Ductal Adenocarcinoma.
- CHK1i: Checkpoint Kinase 1 inhibitor.
- AML: Acute Myeloid Leukemia.
- MCL: Mantle Cell Lymphoma.
- NSCLC: Non-Small Cell Lung Cancer.
- GLOBOCAN: Global Cancer Observatory.
- Liposomal irinotecan: A formulation of irinotecan encapsulated in liposomes.
- Paclitaxel: A chemotherapy drug used to treat various cancers.
- Dexamethasone, promethazine, Cimetidine: Pre-medications often used with IV paclitaxel to manage side effects.
- Taxol-albumin: Refers to albumin-bound paclitaxel (Abraxane).
- Green Energy (綠色能源): Renewable energy sources.