Consistent New Patient Starts and Growing Launch Momentum
Approximately 200 new patient starts with Iptrozy in Q1 (third consecutive quarter of ~200), totaling over 600 since launch; first-line (TKI‑naive) proportion of new starts increased from ~30% to ~40% to now >50%.
Net U.S. Product Revenue Growth
Iptrozy net U.S. product revenue of $18.5M in Q1, representing an 18% sequential increase from the prior quarter and growth from $7.7M to $15.7M to $18.5M over the prior three quarters.
Strong Total Revenue and Collaboration Financing
Total revenue of $83.2M in Q1, including $64.7M in collaboration and license revenue driven by an upfront payment of nearly $60M from Eisai; $1.7M in royalties from Japan and China partnerships (both exceeding expectations).
Robust Clinical Efficacy and Durability
Pooled TRUST data: median duration of response and median progression-free survival ~50 months in TKI‑naive patients; nearly 20 months DOR in TKI‑pretreated (TRUST‑2); pooled OS in TKI‑pretreated nearly 30 months — unprecedented durability in ROS1 NSCLC.
Strong CNS Activity and Guideline Recognition
Intracranial response rate of 66% in second‑line without exclusions; Iptrozy added to NCCN CNS guidelines as a systemic therapy option for ROS1-positive NSCLC with brain metastases, reinforcing differentiated CNS profile.
Favorable Safety and Low AE-Related Discontinuations
In pivotal TRUST studies, 6.5% (of 337) discontinued due to any adverse reaction and only 0.3% discontinued for one of the six most common AEs; real‑world tolerability aligns with clinical trials and supports long on‑therapy durations.
Commercial Awareness and Market Access Progress
Aided awareness among target physicians reached 97%; 100% of the top 50 historical TKI accounts have prescribed Iptrozy; talotrectinib listed on China NRDL supporting rapid uptake in China.
Strong Balance Sheet and Financial Flexibility
Cash, cash equivalents, and marketable securities of $533.7M at quarter end; $50M available under term loan; anticipated ~ $30M milestone from Eisai on EU approval (2027); management expects no additional external financing needed on current plan.
Pipeline and Business Development Progress
Safusitinib advancing (Phase 3 SIGMA), acquisition of Japan rights from Daiichi Sankyo to secure global safusitinib rights and expand SIGMA into Japan; preclinical data support talotrectinib's mechanistic advantages; DDC platform update expected by year end.