TYK Medicines (2410) H1 2024 earnings summary

Executive summary

• Pre-revenue clinical-stage oncology pipeline had 11 candidates, led by TY-9591, with pivotal Phase II and registrational Phase III trials underway in China.

• H1 2024 net loss was RMB219.5m, up 26.3% YoY; an August IPO raised HK$579.3m gross and the post-listing conversion of redemption liabilities to equity strengthened the balance sheet.

Financial highlights

• Revenue and cost of sales were nil in H1 2024 and H1 2023; the next Livzon milestone payment had not been triggered by June 30.

• Total comprehensive loss was RMB219.533m versus RMB173.8m; loss attributable to owners was RMB219.053m versus RMB173.5m.

• R&D costs rose 15.3% YoY to RMB137.758m, mainly on higher trial and testing expenses; administrative expenses rose 80.8% to RMB40.100m, including RMB12.632m of listing expenses.

• H1 loss included a RMB47.459m fair-value loss on redemption liabilities; finance costs rose 21.1% to RMB5.431m.

• Other income and gains increased to RMB11.285m from RMB10.279m.

Outlook and guidance

• TY-9591 brain-metastasis Phase II enrollment targeted for Q3 2024, with a conditional marketing application planned for Q1 2025; L858R Phase III enrollment targeted for Q4 2024 and NDA for H2 2026.

• TY-9591 combination Phase II was expected to start in H2 2024, with enrollment completion planned for H1 2026.

• TY-302 breast-cancer Phase III trial with toremifene planned for Q1 2025, with NDA targeted for H2 2028; prostate-cancer Phase II planned for H2 2024.

• TY-2699a and TY-0540 Phase Ib studies were expected to start in Q1 2025; TY-4028 Phase I trial in NSCLC with exon 20 insertion was planned for December 2024.

• Commercial-scale manufacturing at the Huzhou facility was expected by end-2025; priorities included advancing clinical programs, in-house R&D, commercialization and licensing or collaboration opportunities.