Strong KIMTRAK Revenue Growth
Net revenue of $400,000,000 for 2025, representing a 29% year-over-year increase versus 2024 (underlying growth ~20% when normalized for rebate reserves).
Broad Global Adoption and Market Access
KIMTRAK approved in 39 countries and launched in 30 markets; ~70% penetration across major markets; 150 new accounts activated in 2025; approximately 1,000 patients served per year in metastatic uveal melanoma.
Clinical/Real-World Efficacy Signals
Real-world mean duration of therapy of 14 months (exceeding clinical trial experience); ESMO IO real-world data from 150 patients showing median overall survival of 28 months; one in four patients alive at three years (~25%).
Robust Late-Stage Pipeline with Near-Term Data
Three ongoing Phase 3 trials: TEBE-AM (second-line cutaneous melanoma) with enrollment on track for completion in 2026 and top-line data potentially as early as H2 2026; ATOM (adjuvant uveal melanoma) active in Europe with U.S. sites planned in 2026; PRISM-MEL-301 (brenetafusp in first-line cutaneous melanoma) with IDMC selecting the 160 mcg dose and >200 sites activated, targeting enrollment completion in 2027.
Expansion Beyond Uveal Melanoma
Strategic expansion of PRAME franchise into ovarian and non-small cell lung cancer with combination cohorts; PRAME half-life–extended (HLE) candidate in dose escalation with a comprehensive data package expected in 2026 to inform next steps.
Infectious Disease and Autoimmunity Progress
HIV functional cure program showed dose-dependent antiviral effects with delayed viral rebound at 120 and 300 mcg in early cohorts; hepatitis B candidate showed encouraging Phase 1 results; CTA submitted for type 1 diabetes program (S118I) with a first-in-human dose anticipated in 2026 and preclinical data demonstrating beta-cell protection and preserved insulin secretion.
Improving Financial Position and Discipline
Cash and marketable securities of approximately $864,000,000 at year-end (an increase of >$40,000,000 versus prior year); revenue growth outpaced operating expense growth in 2025, resulting in a reduced operating loss.
Commercial Footprint and Community Penetration
70% of KIMTRAK prescriptions come from community providers and 50% of patient starts occur in the community, supporting broader patient access and potential launch leverage into cutaneous melanoma.