20260330-招银国际-康方生物-09926.HK-Eyes_on_pivotal_ivonescimab_readouts_5页_742kb

Akeso (9926 HK) Summary

Core Content and Key Highlights

Akeso, a biotechnology company listed on the Hong Kong Stock Exchange, reported strong product sales of RMB3.0bn in FY25, marking a 52% year-over-year (YoY) increase, slightly below the previously estimated RMB3.1bn. This growth was driven by the inclusion of cadonilimab for 2L+ CC and ivonescimab for 2L+ EGFR-mutated NSCLC in the National Reimbursement Drug List (NRDL) in January 2025.

For FY26, the company is expected to see further acceleration in revenue growth, fueled by the inclusion of cadonilimab in 1L GC and 1L CC, and ivonescimab in 1L PD-L1+ NSCLC in January 2026. Despite a reported attributable net loss of RMB1.14bn in FY25 (compared to RMB501mn in FY24), Akeso maintains a robust balance sheet with RMB9.2bn in cash and equivalents as of the end of FY25, providing a solid financial foundation for its ongoing late-stage clinical programs.

Key Financial Performance

• Revenue:

  • FY24A: RMB2,124mn
  • FY25A: RMB3,056mn (+43.9% YoY)
  • FY26E: RMB5,010mn (+63.9% YoY)
  • FY27E: RMB8,679mn (+73.2% YoY)
  • FY28E: RMB11,455mn (+32.0% YoY)

• Net Profit:

  • FY24A: RMB-501mn
  • FY25A: RMB-1,140.8mn
  • FY26E: RMB-734mn
  • FY27E: RMB725mn
  • FY28E: RMB1,625mn

• Gross Profit Margin:

  • FY24: 86%
  • FY25: 79%
  • FY26E: 77.43%
  • FY27E: 81.10%
  • FY28E: 82.02%

• Operating Expenses:

  • Selling expenses decreased from 49% to 47% of product sales in FY25.
  • R&D expenses decreased from 56% to 51% of product sales in FY25.

Pivotal Clinical Readouts and Pipeline

• Ivonescimab:

  • Demonstrated a compelling median PFS (mPFS) of 11.1 months vs. 6.9 months in the head-to-head China Phase 3 Harmoni-6 trial (vs. tislelizumab + chemotherapy in 1L sq-NSCLC).
  • Interim OS data readouts are expected this year.
  • Global Phase 3 Harmoni-3 trial (1L sq-NSCLC cohort) is anticipated to report interim mPFS data in 2Q26, with final PFS and interim OS readouts in 2H26.
  • NSq-NSCLC cohort enrollment is targeted for completion in 2H26, with a final PFS readout expected in 1H27.
  • The FDA has set a target action date of November 2026 for the EGFR-TKI resistant NSCLC indication, which could represent the potential first FDA approval for ivonescimab.

• Cadonilimab:

  • Accelerating global expansion through two pivotal trials.
  • Initiated a global Phase 2 registrational trial for cadonilimab plus lenvatinib in IO-resistant 2L HCC.
  • Launching a head-to-head global Phase 3 MRCT of cadonilimab plus chemotherapy vs. chemotherapy + nivolumab in 1L GC, driven by compelling efficacy signals, especially in PD-L1 low-expressing populations.

• IO 2.0 + ADC Strategy:

  • Akeso is advancing its proprietary HER3 ADC and TROP2/Nectin-4 ADC into Phase 2 trials.
  • The company plans to evaluate combinatorial regimens pairing these ADCs with cadonilimab and ivonescimab.

Valuation and Investment Recommendation

• Target Price (TP): HK$185.80 (up from HK$182.12)
• Current Price: HK$126.40
• Upside Potential: 47.0%
• DCF Valuation:
  • Equity value: RMB150,608mn
  • DCF per share: HK$185.80
• Terminal Growth Rate: 4.5%
• Weighted Average Cost of Capital (WACC): 8.37%

Analyst Ratings and Disclaimers

• Rating: BUY
• Rationale: Strong product sales, pivotal data readouts expected, and a solid balance sheet support the BUY rating.
• Sensitivity Analysis: The DCF valuation is sensitive to changes in terminal growth rate and WACC, with the target price of HK$185.80 corresponding to a WACC of 8.37% and a terminal growth rate of 4.5%.

Shareholding and Market Performance

• Shareholding Structure:

  • Green Court Capital: 4.7%
  • Sunny Beach Living: 4.6%

• Stock Data:

  • Market Cap: HK$116,432.5mn
  • 12-month price performance:
    • Absolute: 18.2%
    • Relative: 26.2%

Analyst Certification

• The analyst certifies that the views expressed in the report accurately reflect personal views and that there are no conflicts of interest affecting the report's objectivity.

Important Disclosures

• The report is not tailored to individual investors and does not constitute investment advice.
• Past performance does not guarantee future results.
• CMBIGM is not a registered broker-dealer in the U.S. and may not be subject to U.S. regulations.
• The report is intended for specific recipients in the UK, U.S., and Singapore, and may not be distributed to others without prior consent.