Nxera Pharma (4565) Q4 2023 earnings summary

Executive summary

• FY2023 reflected the acquisition of Idorsia’s Japan/APAC business; revenue was ¥12,766m, Core Operating Loss ¥3,076m and net loss ¥7,150m.

• Priorities for FY2024 include growing PIVLAZ sales, advancing daridorexant in Japan, developing the Japan/APAC commercial business and progressing partnered and in-house programs.

Financial highlights

• Revenue was ¥12,766m ($91m), down from ¥15,569m ($119m) in FY2022, mainly due to no new out-licensing upfront payments; PIVLAZ sales contributed ¥6,109m after acquisition inclusion.

• IFRS Operating Loss was ¥9,526m versus Operating Profit of ¥7,397m in FY2022; Core Operating Loss was ¥3,076m versus Core Operating Profit of ¥5,856m.

• Net Loss was ¥7,150m versus Net Profit of ¥383m in FY2022; non-cash costs and transaction expenses were partly offset by a ¥3,486m tax credit and no equity-accounting costs in 2023.

Outlook and guidance

• FY2024 PIVLAZ NHI-base sales target is ¥16bn+ versus ¥13.4bn in FY2023, supported by its inclusion in updated Japanese stroke guidance.

• FY2024 R&D expense guidance is ¥12bn–¥14bn, including a full year of acquired-business costs and increased discovery, translational medicine and priority-program investment.

• FY2024 S&M and G&A guidance is ¥18bn–¥20bn, including higher amortization, PIVLAZ and daridorexant commercialization support, South Korea launch preparation and ~¥1bn of integration costs.

• Daridorexant’s Japan NDA was submitted in October 2023; potential Japan launch is in Q4 2024, subject to approval, and South Korea commercialization is expected in early 2025.