Ascletis Pharma Inc (1672) H1 2023 earnings summary

Executive summary

• H1 revenue rose 21.7% YoY to RMB46.506m; gross profit increased 58.5% to RMB38.620m, and net loss narrowed 81.2% to RMB16.559m.

• Total income increased 41.3% to RMB121.5m, including RMB75.041m in other income and gains; cash and bank balances of RMB2,512.9m were expected to fund R&D and operations through 2027.

• Five IND approvals were obtained; one Phase I and two Phase II trials were completed, with five candidates in ongoing Phase II or Phase III development.

Financial highlights

• Ritonavir revenue was RMB44.167m versus RMB0.691m; HCV product revenue was RMB2.339m versus RMB4.529m, and promotion service revenue was nil versus RMB32.998m.

• Cost of sales fell 43.1% to RMB7.9m as gross profit rose to RMB38.620m, reflecting revenue growth and improved manufacturing cost control.

• Other income and gains rose 56.9% to RMB75.041m, including bank interest income of RMB49.0m versus RMB13.4m and net FX gains of RMB17.9m versus RMB32.2m.

• R&D expense fell 22.4% to RMB92.3m; administrative expense rose 44.4% to RMB25.9m, while selling and distribution expense fell 92.9% to RMB0.7m.

• Basic and diluted loss per share narrowed to RMB1.52 cents from RMB8.10 cents; net loss margin improved to 35.6% from 230.3%.

Outlook and guidance

• H2 priorities included accelerating ASC41 Phase II for NASH, enrolling 120 ASC40 rGBM patients, completing ASC42 Phase II for PBC, advancing discovery, and pursuing licensing opportunities.

• ASC22 CHB expansion-cohort interim results were expected in Q3 2023; ASC42 PBC Phase II topline data were expected by year-end 2023.

• ASC40 acne Phase III was expected to start in H2 2023; enrollment of ~120 ASC40 rGBM patients for planned interim analysis was expected in Q3 2023.

• ASC41 NASH 12-week interim results from ~42–45 patients were expected in Q4 2023; 52-week ASC40 NASH topline results were expected in Q1 2024.

• ASC10 and ASC11 COVID-19 trials could start by end-2023 or early 2024, conditional on continued epidemic activity and demand for additional oral treatments in China.