TYK Medicines (2410) H2 2024 earnings summary

Executive summary

• 2024 loss widened 1.2% to RMB387.928m as administrative expenses rose, partly offset by lower R&D costs and finance costs.

• Clinical-stage pipeline advanced, led by TY-9591; conditional-marketing NDA submission is targeted for Q2 2025, subject to trial analysis and regulatory progress.

Financial highlights

• Revenue was RMB107k versus nil in 2023; gross profit was RMB14k and gross margin was 13.1%, from R&D technical services.

• Other income and gains rose 20.1% to RMB30.542m, mainly on higher government grants and bank interest income.

• R&D costs fell 5.5% to RMB235.446m, primarily due to lower preclinical R&D expenses; administrative expenses increased 82.7% to RMB108.332m, mainly from listing and operating expenses.

• Loss for the year increased 1.2% to RMB387.928m; listing expenses were RMB27.229m, versus RMB8.004m in 2023.

• Finance costs decreased 42.4% to RMB12.817m, mainly reflecting lower transaction costs on redemption liabilities and lease interest.

Outlook and guidance

• TY-9591 conditional-marketing NDA is targeted for Q2 2025 after planned Pre-NDA submission in April; NDA for the EGFR L858R Phase III program is targeted for 2026.

• TY-9591 combination-trial enrollment is expected to finish in H2 2025; discussion with CDE on a confirmatory study is planned for Q1 2026.

• TY-302 is expected to enter registrational development for breast cancer in 2026; a Phase II prostate-cancer combination trial is planned for H1 2025.

• First-phase factory production lines are expected to obtain GMP compliance certification by end-June 2026, with annual capacity of 150m tablets or capsules after project completion.

• Plans include continued in-house R&D, next-generation ADC development, AI-enabled drug discovery, partnership exploration and expansion of commercialization capabilities.