VISEN Pharmaceuticals (2561) H1 2025 earnings summary

Executive summary

• H1 2025 net loss widened to RMB118.0 million from RMB83.5 million YoY; cash and cash equivalents rose to RMB805.9 million at June 30, mainly from IPO proceeds.

• Lonapegsomatropin’s China BLA is in its second technical review round, with approval expected in Q4 2025 and commercial sales anticipated in 2026.

Financial highlights

• R&D costs rose 19.8% YoY to RMB46.6 million, driven partly by technology transfer and localization; administrative expenses increased 37.6% to RMB60.0 million, including share-based payments and post-listing professional fees.

• Basic and diluted loss per share was RMB1.18 versus RMB0.89; total comprehensive loss was RMB117.9 million versus RMB83.6 million.

• Net other losses were RMB7.1 million, primarily from FX movements; H1 2024 other income included a one-time RMB2.9 million government subsidy.

• Net cash used in operating activities was RMB108.7 million in H1.

Outlook and guidance

• Lonapegsomatropin BLA approval for PGHD is expected in Q4 2025; commercial sales are expected from 2026.

• Small-scale drug-substance technology-transfer runs are targeted by end-2025; full localization is expected in 2027, with locally manufactured product commercialization in 2028 after Local BLA approval.

• Palopegteriparatide’s China Phase 3 open-label extension is expected to finish by end-2025; first Lecheng patient treatment is expected by year-end, subject to approvals.

• CDE consultations on priority review for palopegteriparatide and priority/rare-disease review for navepegritide are expected before year-end.