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生泰 2025Q2 法說會簡報重點與營運摘要

生泰合成工業股份有限公司 (SYN-TECH CHEM. & PHARM. CO., LTD) 2024法說會簡報

Company Overview

  • Establishment Date: 1982年11月9日
  • Capital: 新台幣445,917仟元 (NT$445,917 thousand)
  • Chairman: 蕭振明先生 (Mr. Hsiao Chen-Ming)
  • Employees: 219位同仁 (219 colleagues)
  • Core Values/Principles:
    • 精誠 (Sincerity)
    • 務實 (Pragmatism)
    • 創新 (Innovation)
    • 發展 (Development)

Main Business Scope (Products)

  • 西藥原料藥 (Western pharmaceutical raw materials)
  • 動物用藥 (Veterinary drugs)
  • 賦形劑 (Excipients)

Product Categories

  • 產品一: 肌肉鬆弛劑 (Muscle Relaxants)
  • 產品二: 消化系統藥物 (Digestive System Drugs)
  • 產品三: 中樞神經系統藥物 (Central Nervous System Drugs)
  • 產品四: 局部麻醉劑 (Topical Anesthetic Agents)
  • 產品五: 賦形劑及動物用藥 (Excipient and Animal Drugs)
  • 產品六: 呼吸系統藥物 (Respiratory System Drugs)
  • 產品七: 化學治療藥物 (Chemotherapeutic Drugs)
  • 產品八: 心臟血管劑 (Cardiovascular Agents)
  • 產品九: 消炎解熱鎮痛劑 (Non-Steroidal Anti-Inflammatory Antipyretics and Analgesics)
  • 產品十: 其他 (Others)

Management System Certifications

  • ISO9001品質系統 (ISO9001 Quality Management System)
  • ISO14001環境系統 (ISO14001 Environmental Management System)
  • ISO45001職安衛系統 (ISO45001 Occupational Health and Safety Management System)
  • PIC/S GMP藥品優良製造作業規範 (PIC/S GMP Good Manufacturing Practice for Medicinal Products)
  • GDP藥品優良運銷規範 (GDP Good Distribution Practice for Medicinal Products)
  • ISO14064-1溫室氣體盤查標準 (ISO14064-1 Greenhouse Gas Inventory Standard)

Awards and Recognitions

  • 國家醫藥品質獎 (National Medical Quality Award)
  • 國家磐石獎 (National Stone Award)
  • 藥物科技研究發展獎 (Pharmaceutical Technology Research and Development Award)
  • 國家新創獎 (National Innovation Award)
  • 工業永續精銳獎 (Industrial Sustainability Elite Award)
  • 中小企業創新研究獎 (SME Innovation Research Award)
  • 國家新創獎精進續獎 (National Innovation Award - Advanced Continuation Award)
  • 2024年度淨零產業競爭力卓越獎 (2024 Net-Zero Industry Competitiveness Excellence Award)

All-round Development Areas

  • 人才培訓 (Talent Training)
  • 經營領域 (Business Areas)
  • 基礎建設 (Infrastructure)
  • 學術研究機構合作 (Academic Research Institution Collaboration)
  • 企業整合新藥開發 (Enterprise Integrated New Drug Development)

DMF/MF Registrations

CountryDMF/MF Registration Count
美國 (USA)18
日本 (Japan)16
加拿大 (Canada)3
韓國 (South Korea)5
歐盟 (EU)6
大陸 (Mainland China)4
其他地區 (Other Regions)9

Official Audit Records

AgencyAudits to DateFirst Audit Year
美國 FDA (US FDA)71995
台灣 FDA (Taiwan FDA)212002
韓國 FDA (South Korea FDA)22007
匈牙利 FDA (Hungary FDA)12008
澳洲 TGA (Australia TGA)42009
日本 PMDA (Japan PMDA)52014
墨西哥 FDA (Mexico FDA)12015
歐盟 EDQM (EU EDQM)12016

Customer Audit Records

Audit YearNumber of Audits
20205
20217
202211
202335
202438
2025年1至3月 (Jan-Mar 2025)9

Financial Highlights and Key Metrics

Operating Revenue for the Past Five Years (Unit: 新台幣百萬元)

YearOperating Revenue
2020年984
2021年747
2022年 (追溯調整)986
2023年1,115
2024年1,258
2025年1-3月316

EPS and Cash Dividends for the Past Five Years (Unit: 新台幣元)

Year每股盈餘 (EPS)每股現金股利 (Cash Dividend Per Share)
2020年6.214.0
2021年3.381.93
2022年 (追溯調整)6.623.0
2023年5.633.5
2024年8.825.3
2025年Q11.70 (EPS only, cash dividend not applicable for Q1)

Recent Performance and Results

Revenue Proportion by Product Category (Unit: 新台幣萬元)

2024年 Performance

Product CategoryRevenueProportion
肌肉鬆弛劑 (Muscle Relaxants)44,97136%
消化系統藥物 (Digestive System Drugs)15,06612%
中樞神經系統藥物 (Central Nervous System Drugs)14,74412%
局部麻醉劑 (Topical Anesthetic Agents)14,34311%
賦形劑及動物用藥 (Excipient and Animal Drugs)11,1859%
呼吸系統藥物 (Respiratory System Drugs)7,6786%
化學治療藥物 (Chemotherapeutic Drugs)6,5985%
心臟血管劑 (Cardiovascular Agents)6,0885%
消炎解熱鎮痛劑 (Non-Steroidal Anti-Inflammatory Antipyretics and Analgesics)4391%
其他 (Others)4,6553%

2023年 Performance

Product CategoryRevenueProportion
肌肉鬆弛劑 (Muscle Relaxants)43,09739%
消化系統藥物 (Digestive System Drugs)9,9289%
中樞神經系統藥物 (Central Nervous System Drugs)9,2048%
局部麻醉劑 (Topical Anesthetic Agents)16,57515%
賦形劑及動物用藥 (Excipient and Animal Drugs)12,39511%
呼吸系統藥物 (Respiratory System Drugs)3,1163%
化學治療藥物 (Chemotherapeutic Drugs)3,7453%
心臟血管劑 (Cardiovascular Agents)6,6856%
消炎解熱鎮痛劑 (Non-Steroidal Anti-Inflammatory Antipyretics and Analgesics)1,2781%
其他 (Others)5,4455%

2025年1-3月 Performance

Product CategoryRevenueProportion
肌肉鬆弛劑 (Muscle Relaxants)9,53430%
中樞神經系統藥物 (Central Nervous System Drugs)4,40213%
呼吸系統藥物 (Respiratory System Drugs)4,31613%
消化系統藥物 (Digestive System Drugs)2,59012%
局部麻醉劑 (Topical Anesthetic Agents)2,5188%
賦形劑及動物用藥 (Excipient and Animal Drugs)2,1416%
心臟血管劑 (Cardiovascular Agents)1,2463%
化學治療藥物 (Chemotherapeutic Drugs)1,0283%
消炎解熱鎮痛劑 (Non-Steroidal Anti-Inflammatory Antipyretics and Analgesics)2701%
其他 (Others)3,53011%

2024年1-3月 Performance

Product CategoryRevenueProportion
肌肉鬆弛劑 (Muscle Relaxants)11,10741%
中樞神經系統藥物 (Central Nervous System Drugs)3,12611%
呼吸系統藥物 (Respiratory System Drugs)1,8747%
消化系統藥物 (Digestive System Drugs)6803%
局部麻醉劑 (Topical Anesthetic Agents)3,64814%
賦形劑及動物用藥 (Excipient and Animal Drugs)3,28312%
心臟血管劑 (Cardiovascular Agents)4992%
化學治療藥物 (Chemotherapeutic Drugs)2,5199%
消炎解熱鎮痛劑 (Non-Steroidal Anti-Inflammatory Antipyretics and Analgesics)1491%
其他 (Others)930%

Sales Region Proportion

2024年

RegionProportion
亞洲(台、日外) (Asia except Taiwan & Japan)22%
日本 (Japan)31%
美洲 (Americas)17%
歐洲 (Europe)19%
其他 (Other)1%
台灣 (Taiwan)10%

2025年1~3月

RegionProportion
亞洲(台、日外) (Asia except Taiwan & Japan)25%
日本 (Japan)43%
美洲 (Americas)8%
歐洲 (Europe)10%
其他 (Other)2%
台灣 (Taiwan)12%

Comparison of Operations between 2024 and 2023 (Unit: 新台幣仟元)

項目2024年2023年差異(%)
營業收入 (Operating Revenue)1,257,6651,114,68713
營業毛利 (Gross Profit)486,941409,52119
毛利率(%) (Gross Margin %)39375
營業利益 (Operating Income)350,804281,85124
營業外收入 (Non-Operating Income)137,43431,918331
稅前淨利 (Profit Before Tax)488,238313,76956
本期淨利 (Net Income for the Period)393,284251,01357
每股盈餘(元) (Earnings Per Share (NT$))8.825.6357

Analysis of Key Operational Differences between 2024 and 2023

  • 營收 (Revenue):

    • Mainly due to the gradual recovery of product production and sales after the completion of factory reconstruction, and the growth in export performance to the Japanese market, further driving up revenue.
  • 盈餘 (Earnings):

    • Mainly due to active expansion of export markets, increased production capacity from factory reconstruction, and adjustment of product sales mix.
    • Also due to a significant increase in compensation income and foreign exchange gains, leading to a substantial increase in non-operating income.

Comparison of Operations between Q1 2025 and Q1 2024 (Unit: 新台幣仟元)

項目2025年1-3月2024年1-3月差異(%)
營業收入 (Operating Revenue)315,750269,78217
營業毛利 (Gross Profit)116,398104,84711
毛利率(%) (Gross Margin %)3739(5)
營業利益 (Operating Income)83,27474,61312
營業外收入 (Non-Operating Income)11,44834,617(67)
稅前淨利 (Profit Before Tax)94,722109,230(13)
本期淨利 (Net Income for the Period)75,75187,384(13)
每股盈餘(元) (Earnings Per Share (NT$))1.701.96(13)

Analysis of Key Operational Differences between Q1 2025 and Q1 2024

  • 營收 (Revenue):

    • Mainly due to performance growth in the Japanese export market and increased sales of intermediates.
    • Gradual increase in sales volume through new customer development.
  • 盈餘 (Earnings):

    • Although revenue grew, gross margin decreased due to changes in the product sales mix.
    • Due to a decrease in USD positions, foreign exchange gains, and interest income, leading to a decrease in non-operating income.

Future Outlook and Guidance

  • Disclaimer: This presentation and discussion contain specific forward-looking statements regarding operating results, financial conditions, and expectations for future events. These forward-looking statements inherently involve risks and uncertainties, as they relate to future events and depend on environmental factors at the time of their occurrence. The company is not obligated to publicly update or modify these forward-looking statements, regardless of new information, future events, or other circumstances. Actual results may differ significantly from the content inferred by these forward-looking statements.

Strategic Initiatives and Plans

Product Development and Optimization

  • IMH (Product Name/Code):

    • One batch validation completed, three batches expected to be completed in Q2.
    • AMH quality affirmed by Japanese pharmaceutical manufacturers.
    • Q1 2025 sales of AMH: over 500KG. Estimated 2025 sales of AMH: over 3 metric tons.
    • DFP completed MF (Master File).
    • Q1 2025 sales of DFP: 500KG.
  • Product Process Optimization, Key Step Automation, Providing High-Quality and Reasonably Priced Products:

      1. R&D to improve processes, plan for automation of key steps. CTT and Biotechnology Development Center (DCB) have initially completed improvement plans.
      1. Reconstruction of factory facilities and equipment fully completed. In Q1 2025, CMZ, OPS, PEH increased revenue by over NT$12 million.
      1. R&D of specialized products. TVP product contributed NT$12 million in revenue in Q1 2025.

Future New Niche Products

  • Carefully select and evaluate future new niche products suitable for the company's development.
  • Align with national demand, select products carefully to avoid domestic drug shortages.
  • APB and SBS, which are on Taiwan's essential drug list, are still under R&D by the company.
  • GSB has completed validation.

Expansion into New Business Areas

  • Evaluate key intermediates for active pharmaceutical ingredients (APIs).
  • Expand into the Chinese market, CTT, AMH.
  • Develop small-volume specialty API PRX.
  • New drug collaborative R&D for GFH, license obtained.

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