Strong Revenue Growth and Quarterly Acceleration
Total global revenue of ~$616M for FY2025, driven predominantly by U.S. BRIUMVI net sales of ~$594M. Q4 2025 U.S. net sales were $182.7M (total Q4 net product revenue $189.1M), representing ~92% year‑over‑year growth and ~20% sequential growth versus Q3.
Robust Operating Performance and Profitability (Adjusted)
Operating income for FY2025 was $123M. Reported net income was $447.2M ($2.77 diluted EPS) compared to $23.4M ($0.15) in 2024, noting the FY2025 results include a nonrecurring income tax benefit of ~ $340M from release of a deferred tax asset valuation allowance.
Positive Clinical and Long‑Term Data Supporting Uptake
Six‑year open‑label ULTIMATE I/II extension data showed nearly 90% of patients free from 24‑week confirmed disability progression and extremely low relapse rate (equivalent to 1 relapse per ~83 patient‑years); no new safety signals reported — data cited as a key driver of physician confidence and persistence.
Pipeline Momentum with Near‑Term Catalysts
ENHANCE Phase III (single consolidated 600 mg infusion) enrollment complete with topline data expected mid‑2026 and potential 2027 launch. Subcutaneous BRIUMVI Phase III ~75% enrolled with pivotal topline data expected late 2026/early 2027 and potential 2028 launch. Azer‑cel (allogeneic anti‑CD19 CAR‑T) and earlier‑stage programs (e.g., Myasthenia Gravis Phase I) showing early demand/momentum.
Reaffirmed and Growth‑Oriented 2026 Guidance
Reaffirmed FY2026 U.S. BRIUMVI net revenue guidance of $825M–$850M and total global revenue guidance of $875M–$900M. Q1 2026 U.S. revenue expected to be ~$185M–$190M (sequential growth over Q4). Management cites new patient starts tracking to the strongest level since launch.
Strong Balance Sheet & Capital Allocation Actions
Ended year with >$600M in current assets (including ~$200M cash/cash equivalents & investments, ~$300M AR, ~$140M inventory). Completed $100M share repurchase (≈3.5M shares at $28.55 avg) and Board authorized an additional $100M repurchase program. Management expects positive cash flow in 2026 and beyond.
Commercial Execution and Market Share Gains
Broad‑based growth across academic and community settings, expanding prescriber base, record new patient enrollments, strong persistence, and continued share gains within the IV anti‑CD20 segment driven by efficacy, multiyear safety data and operational advantages (1‑hour, twice‑year maintenance).