3D Medicines (1244) H1 2023 earnings summary

Executive summary

• H1 revenue rose 70.3% YoY to RMB352.6m, driven by Envafolimab sales; gross profit increased 69.6% to RMB325.3m and total comprehensive loss narrowed to RMB190.2m.

• The pipeline comprised 12 candidates, with seven in clinical development, including 3D189 in a global Phase III trial.

Financial highlights

• Revenue was RMB352.6m versus RMB207.0m in H1 2022; cost of sales rose 79.6% to RMB27.3m as Envafolimab unit sales expanded.

• Total comprehensive loss narrowed 41.2% to RMB190.2m; adjusted total comprehensive loss was RMB81.5m versus RMB116.1m.

• Selling and marketing expenses rose 62.8% to RMB221.0m, while R&D expenses fell 12.4% to RMB151.6m; administrative expenses were RMB78.4m, partly reflecting higher share-based payment expense.

• Royalty expense rose to RMB35.1m with higher Envafolimab sales.

• Basic and diluted loss per share was RMB0.79 versus RMB8.41 in H1 2022.

Outlook and guidance

• Management expects Envafolimab sales to continue growing over the next five years and plans global commercialization after MRCT completion and FDA and other major regulatory approvals.

• Plans included submitting two pivotal FDA IND applications in 2023 and targeting innovative-drug launches within three to five years.

• Focus remains oncology immunotherapy, with plans to expand Envafolimab indications globally and develop cancer vaccines.

• The global Phase III 3D189 study was recruiting at ~105 centers; China trial initiation and first patient enrollment were targeted by end-2023.