Strong Quarter-over-Quarter Revenue Growth
Q1 2026 net product revenue of $26.2M versus $9.0M in Q1 2025, an increase of ~191%, driven by U.S. sales and the start of the U.K. launch (U.K. contribution minimal in Q1).
First-Time Positive Gross Margin
Shifted to a positive gross margin in Q1 2026 with $1.6M gross profit (first positive quarter after prior losses), attributed to higher volumes and manufacturing / operational improvements.
Manufacturing and Operational Efficiency Gains
Expect to produce ~2x the product in 2026 versus 2025 while keeping staffing at or below prior-year levels; implemented operational changes including a 13% workforce reduction and process optimizations to reduce hours per product.
Clear Path to Attractive Unit Economics at Peak
Company projects peak ALL gross profit margin of ~65%–70% for AUCATZYL and expects annualized savings of $15M in 2027 once restructuring impacts settle.
Clinical and Real-World Efficacy Signals
ROCCA Consortium real-world data showed strong outcomes: >90% overall response rate, no high-grade CRS reported, and only ~3% high-grade ICANS, supporting the product’s safety/efficacy profile outside trials.
Progressing Launch and Provider Coverage
Approximately 73 U.S. centers active now with plan to exceed 80 centers by year-end; U.K. already with >10 centers active and centralized NHS decision-making aiding faster rollout.
Pipeline Milestones and Development Updates
Multiple upcoming readouts: CARLYSLE follow-up and BOBCAT (progressive MS) initial data and ALARIC initial data by year-end 2026; pediatric CATULUS Phase II and potential registration alignment (data end of 2027); LUMINA Phase II (lupus nephritis) data expected in 2028.
Reiterated Full-Year Revenue Guidance
Reaffirmed 2026 net product revenue guidance of $120M–$135M, indicating management confidence in the commercial trajectory despite early-stage international rollout.
Improving Operating Losses
Loss from operations improved to $59.5M in Q1 2026 from $65.2M in Q1 2025 (an improvement of ~8.7%), reflecting revenue growth and cost actions.