InnoCare Pharma (9969) H2 2023 earnings summary

Executive summary

• FY2023 revenue rose 18.1% to RMB738.5m; reported loss narrowed 27.8% to RMB645.6m, while adjusted loss increased to RMB490.7m from RMB473.7m.

• The pipeline comprised 13 assets and more than 30 ongoing global trials across hemato-oncology, autoimmune disease and solid tumors.

• Progress included orelabrutinib approvals, advancement of clinical programs and commercialization of two products.

Financial highlights

• Revenue was RMB738.5m, up 18.1%; drug sales reached RMB671.6m, while R&D services and IP transfer generated RMB67.0m.

• Orelabrutinib sales rose 18.5% to RMB670.7m, supported by expanded indications, NRDL implementation and commercialization reach.

• Gross profit increased 26.6% to RMB610.1m; gross margin rose to 82.6% from 77.1%, reflecting higher sales volume and lower unit manufacturing costs.

• Reported loss narrowed 27.8% to RMB645.6m; adjusted loss, excluding unrealized FX losses and share-based compensation, was RMB490.7m versus RMB473.7m.

• Other income and gains reached RMB244.2m, including RMB192.3m bank interest; reported R&D expense rose 17.5% to RMB751.2m, while selling and distribution expense fell to RMB366.9m.

Outlook and guidance

• Orelabrutinib sales were expected to grow in 2024 and beyond, supported by NRDL access, new indications, dual-channel implementation and expanded market coverage.

• China filings targeted for 2024 included first-line CLL/SLL orelabrutinib in 2H and tafasitamab plus lenalidomide for r/r DLBCL in 2Q; tafasitamab approval was anticipated in 1H25.

• Orelabrutinib r/r MCL U.S. filing was targeted for 2H24; ICP-723 China NDA filing was targeted by end-2024 or early 2025.

• 2024 plans included ICP-332 Phase III AD enrollment, a second China indication and U.S. trial; ICP-488 psoriasis Phase II topline results were targeted by year-end.