VISEN Pharmaceuticals (2561) H2 2025 earnings summary

Executive summary

• 2025 marked the transition toward commercialization: lonapegsomatropin received NMPA approval in January 2026, with full commercialization planned for 2026.

• Revenue was limited to early Lecheng sales of palopegteriparatide; annual loss widened as development, administrative and pre-commercialization expenses increased.

Financial highlights

• Revenue was RMB165,000, cost of sales RMB146,000 and gross profit RMB19,000 in 2025, all from early palopegteriparatide sales in the Lecheng Pilot Zone.

• Loss for the year widened 39.1% to RMB253.4 million from RMB182.2 million; basic and diluted loss per share was RMB2.44 versus RMB1.95.

• R&D costs rose 3.3% to RMB93.5 million; administrative expenses rose 33.2% to RMB115.1 million, while selling and marketing expenses were RMB31.2 million, all incurred in H2.

• Other income increased 21.1% to RMB11.9 million; net other losses were RMB14.9 million versus net gains of RMB2.4 million, mainly reflecting FX losses.

Outlook and guidance

• Full commercialization of lonapegsomatropin is planned for 2026, focused initially on the self-pay market with a premium, differentiated positioning.

• Palopegteriparatide NDA submission is expected in H2 2026 after completion of its Phase 3 open-label extension and ongoing database analysis.

• Localization validation for lonapegsomatropin is expected to be completed in 2027; commercial supply from local manufacturing is expected after Local BLA approval, targeted for 2028.

• Future priorities include advancing pipeline candidates, expanding indications, building localized manufacturing and growing the endocrine and metabolic pipeline through partnerships.