Revenue Growth (Q4 and Full Year 2025)
Fourth quarter total revenue of $127.6M, up 17% year-over-year; full year 2025 total revenue of $460.2M, up 15% year-over-year.
Strong Cash Position
Ended the quarter with $790M in cash, supporting near-term launches and global R&D investment.
Improved Operating Leverage and Expense Discipline
R&D expenses declined 6% year-over-year for the full year; SG&A expenses decreased 12% in Q4 and 7% for the full year. Loss from operations improved 19% to $229.4M and improved 25% on an adjusted (ex-noncash) basis.
Commercial Product Strength (XACDURO, NUZYRA, ZEJULA)
XACDURO and NUZYRA were cited as strong contributors to Q4 revenue. ZEJULA delivered a strong Q4 driven by first-line BRCA-positive new patient starts. XACDURO saw strong patient demand and expanding hospital adoption despite earlier supply constraints.
VYVGART Market Progress
Physician confidence and patient demand for VYVGART remain stable. Average cycles per patient improved >50% versus 2024 by year-end, with management targeting a guideline-supported minimum of 3 cycles per patient as a near-term objective.
Rapid Global R&D Progress — zoci (DLL3 ADC)
zoci advanced from IND to global registrational Phase III in less than 2 years. Global Phase III in 2L/3L SCLC initiated (approx. 480 patients). Clinical signals include an 80% objective response rate in 10 patients with untreated brain metastases; favorable safety profile with low rates of severe TRAEs. Management expects a potential accelerated approval submission in 2027 and first global approval in 2028 (subject to timelines).
Broader Innovation Pipeline Momentum
Multiple programs advanced: ZL-6201 (LRRC15 ADC) received U.S. IND clearance and initiated global Phase I; ZL-1222 (PD-1/IL-12) in IND-enabling studies; ZL-1311 (MUC17 TCE) IND planned by year-end; ZL-1503 (IL-13/IL-31 bispecific) Phase I/Ib enrolling with first-in-human data expected later this year.
Late-Stage Regional Catalysts
Povetacicept interim analysis for the global RAINIER Phase III in IgAN planned in H1 2026; elegrobart global REVEAL-1 top-line in Q1 2026 and REVEAL-2 in Q2 2026; efgartigimod continuing label-expansion efforts across autoimmune indications.
Product Approvals and Upcoming Launches
TIVDAK expected to be approved in China in H1 2026; COBENFY commercial launch planned in Q2 2026; KarXT commercial launch planned in Q2 2026 (NRDL expected in 2027). FDA approval of Optune Pax for locally advanced pancreatic cancer achieved earlier in the month.