Nxera Pharma Operational Highlights and Consolidated Results for the Fourth Quarter and Full Year 2025

Executive Summary

• Nxera Pharma reported FY 2025 net sales of JPY 13.5 bn (+6.8% YoY) for PIVLAZ® and JPY 4.33 bn (+223.9% YoY) for QUVIVIQ®, delivering a total revenue of JPY 29.62 bn.
• The company recorded an operating loss of JPY 8.46 bn (US$56.5 m) and a net loss of JPY 12.53 bn (US$83.7 m), driven by higher R&D spend, finance costs and one‑off bond amendment expenses.
• Significant strategic milestones were achieved: licensing of vamorolone for DMD in Japan/APAC, Phase 3 success for daridorexant in South Korea, Phase 2 readiness of GPR52 agonist NXE’149, and multiple milestone payments totalling ~US$35 m from partners.

Key Details

• Financial Highlights (FY 2025)
• Revenue: JPY 29,615 mn (US$197.9 m), up JPY 780 mn YoY.
• R&D expense: JPY 14,466 mn (US$96.7 m), +JPN 2,650 mn YoY.
• SG&A expense: JPY 15,225 mn (US$101.7 m), –JPN 790 mn YoY.
• Operating loss: JPY 8,462 mn (US$56.5 m) vs. JPY 5,423 mn prior year.
• Net loss: JPY 12,530 mn (US$83.7 m) vs. JPN 4,838 mn prior year.

• Cash & cash equivalents at 31 Dec 2025: JPY 20,365 mn (US$130.2 m), down JPN 11,903 mn YoY.

• Q4 2025 Commercial Performance

• PIVLAZ® net sales: JPY 4,545 mn (US$30.4 m); market share in Japan rose to 74% (up from 69%).

• QUVIVIQ™ net sales FY 2025: JPY 4,327 mn (US$28.9 m), +223.9% YoY; partial manufacturing/marketing authorization change approved for additional Asian site.

• Licensing & Partnership Activity

• Licensed Japan/APAC rights to vamorolone (AGAMREE®) from Santhera Pharmaceuticals – expands late‑stage portfolio.
• US$3.6 m milestone received from Centessa Pharma for ORX142 OX2R agonist progress.
• US$15 m Phase 3 milestone from Neurocrine Biosciences (NBI‑‘568).

• US$10 m R&D milestone from AbbVie collaboration; US$12 m milestone from Centessa for ORX750/ORX142 Phase 2 start.

• Clinical Development Milestones

• Phase 3 positive results for daridorexant in South Korea; MAA planned Q1 2026, approval expected Q1 2027.
• HTL’732 Phase 1 completed (presented at ESMO 2025); dose identified for Phase 2 expansion now underway.
• GPR52 agonist program regained full rights; NXE’149 ready for Phase 2 with favorable safety data.

• First patient dosed in Phase 2a trial of HTL0039732 (oral EP4 antagonist) for solid tumours.

• Strategic Initiatives

• Restructuring to focus on high‑value platforms; executive cash bonuses reduced by up to 85%.
• Launched proprietary obesity/metabolic pipeline leveraging NxWave™ platform (GLP‑1 agonist + six GPCR programs).

• Established Metabolic Advisory Council for scientific guidance.

• Post‑Period Events

• Assignment of Japan/APAC rights for cenerimod to Viatris; commercial agreement with Holling Bio‑Pharma for daridorexant in Taiwan.

Notable Quotes

“2025 was a year of disciplined execution and strategic progress… I am extremely proud of what our teams have delivered during the year, and I am confident in our ability to build on this momentum as we continue to advance innovative medicines…” – Christopher Cargill, President & CEO

Materiality Assessment: Material – Neutral (the release contains full FY results, significant commercial growth, sizable losses, and multiple strategic milestones that are material to investors.)