20260325-招银国际-科伦博泰生物-B-06990.HK-Inaugural_year_of_commercialization_5页_658kb

Kelun-Biotech (6990 HK) Inaugural Year of Commercialization Summary

Core Content

Kelun-Biotech has marked 2025 as its transformational commercialization year, transitioning from a clinical-stage biotech to a biopharmaceutical company. The company reported total revenue of RMB2.06bn for FY25, representing a 6.5% YoY increase. Pharmaceutical product sales reached RMB543mn, highlighting the rapid scaling of its commercial infrastructure. Despite a widened net loss of RMB382.0mn compared to RMB266.8mn in FY24, the company's financial position remains strong, with RMB4.6bn in cash and financial assets at the end of 2025.

Key Milestones

• Sac-TMT:

  • Secured CNPV (Commissioner's National Priority Voucher) from the FDA in January 2026, enabling an ultra-fast regulatory review process.
  • Achieved positive PFS endpoint in the China Ph3 trial for 1L PD-L1-positive NSCLC when combined with pembrolizumab.
  • Demonstrated positive OS benefits across multiple indications, including 2L EGFRm NSCLC, 3L EGFRm NSCLC, 2L+ TNBC, and 2L+ HR+/HER2- BC.
  • Expected to be submitted for BLA (Biologics License Application) in 2026 for $2L+ endometrial cancer.
  • Potential FDA approval in late 2026 or early 2027.
  • MSD is expected to evaluate combination potential of Sac-TMT with its PD-1/VEGF bispecific in first-line settings.

• A167 and A140:

  • Secured NRDL inclusion effective Jan 2026, setting the stage for volume growth in 2026.

• Additional Out-Licensing:

  • The ITGB6 ADC was licensed to Crescent in late 2025, contributing to a revised DCF-based TP from HK$498.55 to HK$507.11.

Financial Performance (FY24A to FY25A)

Shareholding and Stock Data

• Shareholding Structure:

  • Kelun Pharma: 68.5%
  • MSD: 6.1%

• Stock Data:

  • Market Cap (HK$ mn): 98,171.3
  • Average 3 months turnover (HK$ mn): 233.0
  • 52-week High/Low (HK$): 577.50 / 242.00
  • Total Issued Shares (mn): 233.2

Valuation and DCF Analysis

• DCF Valuation (RMB mn):

  • 2026E: 101,341
  • Net Debt (RMB mn): -2,719
  • Equity Value (RMB mn): 104,060
  • DCF per share (HK$): 507.11

• Terminal Growth Rate: 3.5%

• WACC: 8.69%

• Cost of Equity: 12.0%

• Cost of Debt: 3.0%

• Equity Beta: 0.90

DCF Sensitivity Analysis (HK$)

Earnings and Profitability

Key Outlook and Recommendations

• Maintain BUY recommendation.
• Target Price (HK$): 507.11 (up from 498.55).
• Upside/Downside: 20.5% from current price HK$421.00.

Financial Highlights

• Operating cash flow remains negative in FY26 but is expected to improve significantly in FY28.
• Net cash from financing is positive in FY25 and FY26, supporting growth and development.
• Capital expenditure is expected to remain stable at RMB150mn in FY26, increasing to RMB200mn in FY27 and FY28.
• FCFF (Free Cash Flow to Firm) is projected to turn positive in FY28, reaching RMB8,803mn.

Conclusion

Kelun-Biotech is on a strong trajectory, with a robust financial position and significant progress in its commercialization efforts. The success of the Sac-TMT Ph3 trial and NRDL inclusion for its core assets are key catalysts for future growth. The BUY recommendation is maintained, with a target price of HK$507.11, reflecting the company's potential for substantial returns over the next 12 months.