VISEN Pharmaceuticals (2561) H2 2024 earnings summary

Executive summary

• Late-stage endocrine pipeline: lonapegsomatropin’s China BLA was accepted in March 2024; approval is expected in H2 2025, with launch planned later that year.

• No product sales revenue to date; 2024 preliminary loss narrowed to RMB182.2 million from RMB249.6 million in 2023, largely reflecting the absence of the prior-year procurement-contract loss.

Financial highlights

• 2024 preliminary: other income RMB9.9 million; net other gains RMB2.4 million versus net losses of RMB106.7 million in 2023.

• 2024 preliminary R&D costs rose to RMB90.5 million from RMB57.7 million in 2023; administrative expenses increased to RMB86.4 million from RMB79.9 million.

• 2024 preliminary loss was RMB182.2 million; 2022 and 2023 losses were RMB289.0 million and RMB249.6 million, respectively.

• 9M 2024 total comprehensive loss was RMB129.7 million; operating cash outflow was RMB102.4 million, versus RMB155.7 million in 9M 2023.

• No product sales revenue; 2023 included a one-time RMB109.0 million loss from cancelling a reserved drug-substance procurement commitment.

Outlook and guidance

• Lonapegsomatropin BLA approval expected in H2 2025; commercial launch is anticipated later in 2025, with cash inflow expected from Q2 2026.

• Palopegteriparatide China NDA submission is expected in 2025; the China Phase 3 open-label extension continues.

• Technology transfer and localization with WuXi Biologics are expected to complete in 2027; local BLA approval and locally manufactured product commercialization are expected in 2028.

• Estimated Global Offering net proceeds are HK$603.3 million at the indicative midpoint; funds are planned mainly for lonapegsomatropin development, registration and launch.