Beijing Luzhu Biotechnology (2480) H2 2023 earnings summary

Executive summary

• 2023 listing and advanced LZ901: China Phase III began in September, with 26,000 subjects enrolled by January 2024; Phase II results were statistically and clinically meaningful, with no serious or Grade IV adverse events.

• Reported loss narrowed substantially as the prior-year fair-value charge on financial liabilities did not recur; adjusted loss rose on higher R&D spending tied to LZ901 Phase III.

Financial highlights

• Loss before tax and total comprehensive loss were RMB249.4m in 2023 versus RMB725.2m in 2022; 2022 included a RMB551.5m fair-value loss on financial liabilities at FVTPL.

• Adjusted loss, excluding the fair-value loss and listing expenses, was RMB222.9m versus RMB152.1m, up 46.6% YoY.

• Revenue was nil in both years; other income rose 44.3% to RMB20.1m, primarily from higher bank interest income.

• R&D expenses increased 88.9% to RMB172.7m, mainly reflecting LZ901’s China Phase III trial; administrative expenses rose 1.4% to RMB87.0m.

• Basic and diluted loss per share were RMB1.25 in 2023 versus RMB4.98 in 2022.

Outlook and guidance

• LZ901 China BLA filing is expected in Q4 2024, with commercialization targeted for Q4 2025; U.S. Phase I completion is planned for Q2 2024.

• K3 Phase III in China is planned for H2 2024, with completion in 2025 and commercialization expected in 2026; K193 Phase I completion is expected in H2 2024.

• Priorities include advancing clinical and preclinical candidates, expanding production capacity, planning commercialization in China and abroad, and growing the pipeline through internal development or collaboration.

• Global Offering proceeds are expected to be fully used by 2026; K3 planned-trial proceeds are scheduled for use by end-2024.