Overall Revenue Slightly Increased
Total revenue rose to JPY 29.6 billion from JPY 28.8 billion in FY2024, a modest increase of JPY 0.8 billion (~2.8% year-on-year).
Strong Product Sales Growth
Product sales increased from JPY 14.0 billion to JPY 17.8 billion, up JPY 3.8 billion (~27.1% YoY), driven primarily by PIVLAZ and QUVIVIQ product supply and royalties.
PIVLAZ Market Leadership and Revenue
PIVLAZ delivered JPY 13.5 billion in sales (reported as $13.5 billion figure in presentation context) with ~7% year-on-year growth; domestic market share expanded from 34% in 2022 to 74% in 2025 and cumulative patients reached 25,470 since launch.
QUVIVIQ Rapid Expansion
QUVIVIQ net sales grew from JPY 1.3 billion in 2024 to JPY 4.3 billion in 2025 (+224% YoY). Regulatory/operational improvements (2-week prescription limit ended Dec 2025 and second API approval Oct 2025) support expected ~30% revenue growth in FY2026 and a FY2026 sales range guidance of JPY 5–7 billion for the product.
Commercial Business Profitability
Commercial (pharma-type) business returned to core operating profitability, reported at JPY 6.5 billion on a core basis, supporting management's strategy to stabilize revenues via Japan/APAC commercial growth.
Pipeline Advancements and Partner Momentum
Progress across partnered and in-house programs: Neurocrine muscarinic portfolio advancing (lead M4 agonist direclidine in Phase III with top-line expected by end-2027); Centessa's ORX-750 moving toward registrational program (Q1); two wholly owned assets (NXE'149 GPR52 and NXE'744 EP4) are Phase II–ready and in competitive licensing processes.
Positive Early Clinical Signals
NXE'744 (gut-restricted EP4 agonist) showed strong target engagement with ~50% reduction in indomethacin-induced permeability in an interim study and high gut tissue levels with no concerning safety signals; NXE'149 (GPR52) showed CNS penetration and cognitive/alertness signals in Phase I; NXE'732 (EP4 antagonist) produced two partial responses in Phase I.
In-license of Late-stage Rare Disease Asset (vamorolone/AGAMREE)
Company in-licensed vamorolone for Duchenne Muscular Dystrophy (DMD) for Japan/Korea/Australia/NZ, a late-stage rare disease product with expected strong strategic fit and ~70% commercial overlap with PIVLAZ to enable sales synergies and efficient market penetration.
Operational Efficiency Initiatives
Management changes, pipeline refocus, completion of most post-merger integration investments, and target cost reductions (aiming to reduce total costs >10%) were initiated, with management expecting benefits to appear in H2 FY2026.
Guidance and Ambitious FY2026 Targets
Management set clear FY2026 objectives including net product sales > JPY 19.5 billion (PIVLAZ + QUVIVIQ), securing ≥1 additional late-stage product for Japan/APAC, signing high-value out-licenses, initiating ≥1 new Phase II trial with a partner, and achieving full-year IFRS profitability if execution and milestones align.