Record First-Quarter Revenue and Strong Top-Line Growth
Reported highest-ever Q1 total revenues of approximately $1.07–$1.10 billion, representing more than 19% year-over-year growth; non-GAAP adjusted EPS of $6.34 and reaffirmation of full-year 2026 revenue guidance of $4.25 billion to $4.5 billion.
Robust Oncology Performance
Oncology portfolio grew 45% year-over-year, driven by strong uptake of Zepzelca and early traction for Midevo and ZYHERA; Zepzelca net product sales increased 60% to $101 million in Q1; ZYHERA generated $13 million and is positioned for potential rapid uptake in GEA pending FDA decision.
Breakthrough Zanidatumab Data and Regulatory Milestone
Horizon GEA trial triplet arm delivered a median overall survival (OS) of 26.4 months (improvement of >6 months vs prior HER2-positive metastatic GEA studies) and median duration of response of 20.7 months; supplemental BLA for zanidatumab (ZYHERA) accepted with Priority Review and PDUFA date of 08/25/2026.
Strong Performance in Sleep and Epilepsy Franchises
Xywav net product sales increased 18% to $408 million with ~425 net patient adds and ~16,600 active patients; Epidiolex net product sales increased 15% to $250 million with 16% volume growth, driven by adult and long-term care expansion.
Successful New Product Launch and Early Uptake
Midevo generated $41 million in Q1 with ~500 patients treated since its August 2025 launch; management cites strong unmet need and believes the product can reach a ~$500 million peak U.S. opportunity, supported by ACTION trial pursuing earlier-line use.
Cash Generation and Strong Balance Sheet
Generated $408 million of cash from operations in Q1 and ended the quarter with $2.9 billion in cash and investments, providing flexibility for R&D, commercial investment and business development.
Pipeline Momentum and Upcoming Catalysts
Multiple registrational and early-stage zanidatumab trials progressing (including a breast cancer post-ENHERTU trial and planned interim OS readouts midyear); ACTION trial interim OS readout anticipated late 2026/early 2027; additional data planned to be presented at ASCO.