Jiangsu Recbio Technology (2179) H1 2023 earnings summary

Executive summary

• H1 2023 remained pre-commercial, with no revenue and a net loss of RMB276.9m, down from RMB357.1m year over year; vaccine R&D and manufacturing build-out continued.

• Lead programs were REC603, an HPV 9-valent vaccine in Phase III; ReCOV, with overseas emergency-use authorization and China regulatory plans; and REC610, a recombinant shingles vaccine entering clinical development.

Financial highlights

• Loss before tax and period loss were RMB276.9m versus RMB357.1m in H1 2022; loss attributable to owners was RMB272.5m versus RMB349.7m.

• Basic and diluted loss per share improved to RMB0.57 from RMB0.75; no revenue was generated during the period.

• Other income and gains fell 24% to RMB59.9m, mainly due to lower FX gains, partly offset by higher interest income.

• R&D costs declined 30% to RMB247.8m; clinical-trial costs fell to RMB105m from RMB179m and pre-IND costs to RMB13m from RMB64m.

• Operating cash outflow rose to RMB370.7m from RMB239.5m; administrative expenses were RMB78.1m versus RMB76.7m, and selling and distribution expenses were RMB5.4m versus RMB3.8m.

Outlook and guidance

• REC603 Phase III follow-up reached Month 18, with Month 24 visits underway; interim analysis will use pathological endpoints, and BLA submission is targeted for 2025 subject to conditions.

• ReCOV completed Phase III enrollment and vaccination and remained in follow-up; efficacy data are to be analyzed before a possible China regulatory submission, subject to required conditions.

• REC610’s China clinical-trial application was accepted; preparation for trials is underway, while its Philippines Phase I study reported favorable safety and tolerability at 30-day follow-up after two doses.

• Priorities include accelerating R&D, clinical trials and commercialization, strengthening technology and talent capabilities, and pursuing domestic and international partnerships and expansion.