Strong CARVYKTI Sales Growth
CARVYKTI net trade sales were approximately $555 million in Q4 2025, up 66% year-over-year and 6% quarter-over-quarter; U.S. net trade sales were $420 million (up 38% YoY, 6% QoQ) and ex-U.S. sales were $135 million (over threefold YoY, 5% QoQ).
Robust Overall Revenue and Margins
Company revenue for the quarter was $306 million, a 64% year-over-year increase. Gross margin remained strong at 61% overall, with a 57% gross margin on CARVYKTI net product sales; gross margins have stabilized at ~57% in recent quarters.
Operating and Adjusted Profitability Trajectory
Operating margin improved from -142% in Q2 2023 to -6% in Q4 2025. Operating loss narrowed to approximately -$20 million (a 75% improvement YoY). Adjusted net income turned positive at $2.5 million (vs. a $59 million adjusted net loss prior-year) and adjusted diluted EPS was $0.01 (vs. -$0.15 prior-year).
Large Patient Base and Global Footprint
More than 10,000 multiple myeloma patients have been treated with CARVYKTI. The therapy is available at 294 global treatment sites across 14 markets; in the U.S., 145 authorized centers (with community hospitals comprising about one-third) and ~80% of patients live within 50 miles of a treatment site.
Manufacturing Capacity and Success Rates
Installed capacity supports annual production of 10,000 doses across the manufacturing network with plans and partner J&J backing to expand capacity toward ~20,000 doses. Commercial manufacturing data (Jul 2024–Oct 2025) showed ~99% products successfully manufactured overall, with out-of-spec rates of ~6.5% for patients with 1–3 prior lines and ~9.2% for 4+ prior lines; company reports continuous improvement.
Compelling Long-Term Clinical Data
CARTITUDE analyses showed durable responses: triple-class exposed MM patients with 3 prior lines achieved median PFS of 50.4 months after a single CARVYKTI infusion. CARTITUDE-4 standard-risk patients: 80% progression-free and off treatment at 2.5 years; of those progression-free at 1 year, 93% remained progression-free and alive at 2.5 years.
Pipeline and Development Momentum
Advanced programs beyond CARVYKTI: LUCAR-G39D (allogeneic gamma delta CAR-T) demonstrated manageable safety and encouraging activity; first in vivo CAR-T program moved from candidate selection to first patient dosing in ~6 months. Company expects 1–2 U.S. INDs by year-end and plans to present in vivo clinical data potentially mid-year 2026.
Balance Sheet and Cash Position
Ended the year with $949 million in cash, cash equivalents and time deposits. Operating cash flow outlay improved to $12 million this quarter versus $82 million outlay in the prior-year period, providing optionality to invest in in vivo programs, BD and capacity expansion.
Commercial Adoption Trends Favor Earlier Lines
Approximately 65% of CARVYKTI patients are now being treated in the second through fourth line setting, outpatient administration accounts for ~50% of prescribing volume, and the fastest growth continues in second and third line segments—supporting the company's focus on earlier-line penetration.