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The call conveyed strong commercial execution and substantial pipeline/regulatory progress that drove record Q1 revenue, robust product-level growth (notably oncology, Xywav and Epidiolex), solid cash generation and clear near-term catalysts (zanidatumab PDUFA, multiple interim readouts). Headline growth was partially boosted by an extra shipping week and FX effects, and management highlighted expected competitive dynamics in sleep and areas of margin and policy uncertainty. Overall, the positives (record revenue, high growth rates, cash strength, promising pivotal data and imminent regulatory milestones) outweigh the outlined risks and uncertainties.
Jazz reaffirmed full‑year 2026 non‑GAAP guidance of $4.25–$4.50 billion in revenue after a very strong start: Q1 record revenue of ~$1.07B (reported as $1.1B) and >19% YoY growth, non‑GAAP adjusted EPS of $6.34, and operating cash flow of $408M, with $2.9B in cash and investments at quarter‑end. Management said Q1 growth was led by oncology (+45%), Xywav (+18% to $408M; ~16,600 patients, ~425 net adds), Epidiolex (+15% to $250M; volume +16%), Zepzelca (+60% to $101M), Midevo ($41M; ~500 patients treated) and ZYHERA ($13M); Q1 benefitted from 13 shipping weeks (+~2 ppt) and FX (+~1.5 ppt). They noted a slight non‑GAAP gross margin decline, SG&A down ~$164M (but up ~$8M ex‑litigation), R&D up ~$13M, a modestly lower non‑GAAP tax rate, and reiterated assumptions of 2H headwinds in sleep (generic high‑sodium oxybates and potential new wake‑promoters), declining Xyrem/authorized‑generic revenues, and reduced second‑line Zepzelca use.
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.
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.
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.
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.
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.
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.
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.
Good day, and thank you for standing by. Welcome to the Jazz Pharmaceuticals plc 2026 first quarter earnings conference call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded.
I would now like to turn the conference over to your speaker for today, John Bluth, Head of Investor Relations. Please go ahead. Thank you, and good afternoon, everyone.
Today, Jazz Pharmaceuticals plc reported its first quarter 2026 financial results. The slide presentation accompanying this webcast is available on the Investors section of our website along with the press release and quarterly report on Form 10-Q for the first quarter ended 03/31/2026. On the call today are Renée Galá, President and Chief Executive Officer, Samantha Pearce, Chief Commercial Officer, Robert Iannone, Global Head of R&D and Chief Medical Officer, and Philip L. Johnson, Chief Financial Officer. On slide two, I would like to remind you that today's webcast includes forward-looking statements, such as those related to our future financial and operating results, growth potential, and anticipated development, regulatory and commercial milestones, which involve risks and uncertainties that could cause actual events, performance, and results to differ materially from those...