康霈生技 (Caliway Biopharmaceuticals) 6919 2025Q1 法說會簡報

Company Overview

• Company Name: 康霈生技 (Caliway Biopharmaceuticals)
• Stock Code: 股票代號: 6919 (TWSE 6919)
• Slogan: 改變市場的創新 (Transforming the Market with Innovation)
• Mission: To Bring Market Transforming Innovations that Make Life Amazing!
• Positioning: 國際醫美新藥的創新領導者 (Innovative Leader in International Aesthetic New Drugs)
• Operations Headquarters: 台灣新北市 (New Taipei City, Taiwan)
• Establishment Date: 2012年10月 (October 2012)
• Market Value: 新台幣1,243億 (~USD 4.1B) as of 2025/05/20
• Shares Issued: 153,828,786
• Number of Employees: 49位 (as of 2025/4)

Management Team

• 徐圭暉 (Hui-Hui Hsu) - 董事長 (Chairman)
• 凌玉芳 (Yu-Fang Ling) - 執行長兼研發長 (CEO & CSO)
• 袁照晶 (Chao-Ching Yuan) - 副總經理 (Vice General Manager)
• 張慧敏 (Hui-Min Chang) - 財會處長兼代理發言人 (Head of Finance & Accounting and Acting Spokesperson)
• 彭賢禮 (Hsien-Li Peng) - 醫師 (Physician) - Taiwan
• Michael Gold - 醫師 (Physician) - Nashville, U.S.A
• Greg Goodman - 醫師 (Physician) - Melbourne, Australia
• Joel Schlessinger - 醫師 (Physician) - Omaha, U.S.A

Financial Highlights

• Market Value: 新台幣1,243億 (~USD 4.1B) as of 2025/05/20
• Shares Issued: 153,828,786
• Capital Increase:
  • Completed NTD 3.04 billion cash capital increase (Dec 2023)
  • Completed NTD 6.4 billion IPO capital increase (Oct 2024)

Recent Performance and Results

Company Milestones

• 2021:
  • Feb: CBL-514 Local Fat Reduction Phase 2a achieved final statistical data, efficacy and safety met standards.
• 2022:
  • Jan: CBL-514 Local Fat Reduction Phase 2 stage 1 efficacy data met standards.
  • Feb: CBL-514 Dercum's Disease Phase 2 approved by US FDA.
  • Aug: CBL-514 Moderate/Severe Cellulite Improvement Phase 2 approved by US FDA.
  • Dec: Officially listed on Emerging Stock Market.
• 2023:
  • Jan, Jul: CBL-514 Local Fat Reduction 2 Phase 2b approved by US FDA.
  • Sep: CBL-514 Dercum's Disease Phase 2 data met standards; CBL-514 Local Fat Reduction Phase 2 Stage 2 (CBL-0202) data met standards.
• 2024:
  • Jan: CBL-514 Dercum's Disease Phase 2b approved by FDA; CBL-514 Local Fat Reduction Global Pivotal Phase 3 approved by Australia.
  • Feb: CBL-514 for Dercum's Disease granted US FDA FTD, ODD.
  • Apr: CBL-514 Moderate/Severe Cellulite Improvement Phase 2 data met standards.
  • Oct: Listed on TWSE.
  • Nov: CBL-514 for Dercum's Disease granted EU EMA ODD.
  • Dec: Included in Taiwan Developed Index, Taiwan Mid-Cap 100 Index; CBL-514 Local Fat Reduction Phase 2b (CBL-0204) data met standards.
• 2025:
  • Feb: CBL-514 Local Fat Reduction Final Phase 2b (CBL-0205) data met standards; Included in MSCI World Small Cap Index.

CBL-514 Key Takeaways

• Treatment Efficacy:

  • Local Fat Reduction:
    • 32% of subjects improved by ≥2 grades after treatment (CBL-0204).
    • 58.8% of subjects improved by ≥1 grade with only 1 treatment.
  • Moderate/Severe Cellulite:

    • 95% of subjects showed significant improvement in thigh cellulite.

  • Dercum's Disease:
    • 65% of painful lipomas reduced by >50%.
    • 38.7% of lipomas completely cleared.
    • Reduced pain score by 4.7 points.

• Safety:

  • No serious adverse events related to CBL-514 occurred ("0" case of SAE reported).
  • Only mild to moderate injection site reactions observed.
  • All adverse events resolved within 28 days.

Future Outlook and Guidance

New Drug Development Pipeline

• CBL-514:
  • 2025 Q3: First global pivotal Phase 3 (CBL-0301) to start enrollment in US, Canada.
  • 2025 Q4: Second global pivotal Phase 3 (CBL-0302) to start enrollment in US, Canada, Australia.
• Other Candidates:
  • CBL-514D (Dercum's Disease): Phase 2b statistical data expected by 2026 Q3.
  • CBL-514 (Weight Rebound Combined with GLP-1R Agonist): Phase 2 IND submission Q4 2025.

Strategic Initiatives and Plans

• Global Patent Strategy:

  • All Caliway new drugs are self-developed with global patent rights (118 filings, 77 approved).
  • CBL-514's patents include 100 applications filed, with extensions planned until at least 2045.

• Dual-Engine Profit Model:

  • Engage in global licensing partnerships and regional sales licensing to enhance revenue.

Key Charts, Graphs, and Data Points

US BMI Population Distribution

• Median BMI: 27.
• BMI < 30: 60.7%
• BMI >= 30: 39.3%.

Products, Services & Technology

Core Products

• CBL-514:
  • Indications: Reduction of Subcutaneous Fat, significant reductions in fat volume, no SAEs reported.
• CBL-514D:
  • Indication: Dercum's Disease; granted FDA FTD and ODD.
• Pipeline Candidates:
  • CBF-520: Central Obesity.
  • CBA-539: Hyperpigmentation, Anti-skin Aging.

Technology Platform

• Specific promotion of adipocyte apoptosis: Targeted fat reduction mechanism without damaging surrounding cells.

Important Product Names, Terms, and Concepts

• Products/Candidates: CBL-514, CBL-514D, CBF-520, CBA-539
• Regulatory Terms: FDA, EMA, IND, ODD, FTD

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