Record Quarterly and Annual Revenues
Q4 2025 net product revenue of $243.8M, up 21% year-over-year from $201.3M; full year 2025 WAKIX net product revenue of $868.5M, marking the highest quarterly and strong annual performance.
Sustained Patient Growth
Q4 marked the third consecutive quarter with approximately 400+ average patient adds (first time in franchise history), bringing WAKIX to ~8,500 average patients and supporting further growth opportunity within an estimated 80,000 diagnosed narcolepsy patients.
Blockbuster Guidance for 2026
Company reiterated guidance for WAKIX net revenue of $1.00B to $1.04B for 2026 (first time guiding to blockbuster status for the franchise).
Strong Cash Generation and Balance Sheet
Generated $348.2M of cash from operations in 2025 and ended Q4 with $882.5M in cash, cash equivalents and investments, providing capacity to fund pipeline advancement and BD opportunities.
Pipeline Advancements and Multiple Near-Term Catalysts
Five ongoing Phase III registrational trials across distinct CNS indications; pitolisant GR on track for NDA submission in Q2 2026 with target PDUFA Q1 2027; pitolisant HD top-line data expected in 2027 (PDUFA 2028); EPX-100 registrational programs enrolling with top-line data expected H1 2027 (PDUFA 2028); orexin-2 agonist BP1.15205 Phase I PK data expected mid-2026.
Label Expansion — Pediatric Cataplexy
FDA approval (Feb 13, 2026) of WAKIX for treatment of cataplexy in patients ≥6 years old, expanding indication to pediatric population and advancing path toward pediatric exclusivity (an additional 6 months regulatory exclusivity).
IP and ANDA Litigation Progress
Settled with 6 of 7 ANDA filers; based on settlements, potential generic entry would be no sooner than March 2030 if pediatric exclusivity is obtained (company states it is on track to obtain it); company confident in IP and will continue to defend it.
Clinical Efficacy Signals in Epilepsy Asset
EPX-100 label-extension/OLE data showed clinically meaningful seizure reductions (~50% median reduction and ~50% of patients with ≥50% reduction after ≥6 months exposure) with generally favorable tolerability and no new monitoring requirements.
Commercial Investments and Execution
Commercial organization expanding field-based teams by ~20% (field sales >10%, field reimbursement >50%, remote sales >10%) and launching process improvements including a new patient portal to shorten time to dispense and boost conversion.