Nxera Pharma (4565) Q2 2025 earnings summary

Executive summary

• Revenue rose 19% year-over-year to JPY 15,094 million, driven by PIVLAZ and QUVIVIC growth, milestone payments, and strong commercial momentum in Japan/APAC.

• PIVLAZ and QUVIVIC anchored commercial performance, with PIVLAZ net sales up 7.6–8% and QUVIVIC contributing royalty and supply income.

• Multiple late-stage clinical programs advanced, including new proprietary obesity/metabolic disorder programs and key milestones with partners such as Eli Lilly, Neurocrine, and Centessa.

• Management team strengthened with new directors and Head of IR, and governance structure streamlined.

• FY2025 objectives include achieving JPY 17 billion+ in net product sales, in-licensing at least one late-stage asset, and positive operating profit under IFRS if the GPR52 option is exercised.

Financial highlights

• H1 FY2025 revenue reached JPY 15,094 million, up 18.7–19% year-over-year, with commercial revenue up 66% and platform revenue down 16%.

• Core operating profit for H1 was JPY 364 million, down from JPY 1,176 million year-over-year due to higher R&D investment.

• Operating loss (IFRS) improved to JPY -2,756 million from JPY -3,654 million year-over-year; net loss narrowed to JPY 3,137 million from JPY 4,703 million.

• R&D expenses increased 47% year-over-year to JPY 7,474 million, while SG&A expenses decreased 6%.

• Milestone and upfront payments included USD 10 million from Viatris, USD 15 million from Neurocrine, and USD 4.8 million from Centessa.

Outlook and guidance

• FY2025 guidance unchanged: R&D expenses expected at JPY 12,000–14,000 million, SG&A at JPY 15,000–17,000 million.

• Product sales targets: JPY 13.0–14.0 billion for PIVLAZ and JPY 4.0–5.0 billion for QUVIVIC royalty and supply.

• R&D expenditure to reduce in H2 as several programs move into later stages; focus on in-licensing late-stage assets.

• Long-term goal to reach JPY 50 billion in core revenue by FY 2029-2030, a 25% CAGR from 2023.

• No full-year financial forecast provided due to unpredictability of milestone and upfront payments.