Cutia Therapeutics (2487) H1 2023 earnings summary

Executive summary

• Dermatology-focused portfolio comprised nine products and candidates across four treatment and care areas; five candidates were clinical-stage and four preclinical-stage.

• H1 revenue rose to RMB34.3 million from RMB0.7 million, while the reported loss widened to RMB1,640.3 million, principally reflecting a large fair value loss on convertible redeemable preferred shares.

• Progress included Phase III trial completions or readouts for CU-40102, CU-10201 and CU-30101, and start-up of commercial-scale manufacturing facilities.

Financial highlights

• Revenue increased 5,119.3% YoY to RMB34.3 million from RMB0.7 million, primarily on higher sales of scalp and skin care products.

• Gross profit rose to RMB21.3 million from RMB0.5 million; gross margin declined to 61.9% from 68.8%, mainly due to increased e-commerce promotions.

• Other income increased to RMB21.5 million from RMB3.6 million, while other gains declined to RMB32.3 million from RMB54.8 million, mainly on lower FX gains.

• Reported loss reached RMB1,640.3 million versus RMB251.6 million; the RMB1,454.3 million preferred-share fair value loss was the primary driver of the increase.

• R&D costs were RMB90.1 million, up 8.0%; administrative expenses rose 113.7% to RMB87.9 million and selling and distribution expenses rose 871.1% to RMB58.0 million.

Outlook and guidance

• H2 2023 priorities included accelerating development of CU-40102, CU-40101, CU-20401 and CU-30101, alongside other pipeline candidates.

• CU-40102 primary endpoint readout was expected in Q4 2023, with NDA submission planned for Q4 2023 and China commercialization approval expected in 2024.

• CU-10201 NDA submission was expected in Q4 2023, with China commercialization approval expected in 2024; CU-40101 Phase I primary endpoint readout was expected in Q4 2023.

• CU-20401 Phase II for submental fat was expected to start in Q3 2023; planned milestones also included CU-10101 IND submission in Q2 2024 and CU-30101 NDA submission in 2025.