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Jazz Pharmaceuticals plc: Q1 FY2026 earnings call

What management said about Q1 FY2026, from the documents filed with the SEC on 5 May 2026: press release. Guidance figures: 1 raised, 8 kept. The quarter’s numbers.

Key takeaways

  • Revenue grew 19% year over year: Total revenues were $1,068.9 million versus $897.8 million, up 19%, driven by Xywav, Zepzelca and Epidiolex/Epidyolex net product sales and the inclusion of Modeyso. Source
  • GAAP EPS positive after prior-year loss: GAAP diluted EPS was $4.43 versus a loss of $1.52 a year earlier; non-GAAP adjusted diluted EPS was $6.34 versus $1.68. The GAAP result included a $122.8 million gain on the PRV sale. Source
  • Xywav added 425 net patients: Xywav net product sales rose 18% to $408 million. Approximately 16,600 active patients exited the quarter, of whom about 11,075 had narcolepsy and 5,525 idiopathic hypersomnia. Source
  • Zepzelca growth from first-line use: Zepzelca sales rose 60% to $101 million, driven by the first-line maintenance combination with atezolizumab, partly offset by lower second-line use, which management expects to decline through the year. Source
  • SG&A fell sharply year over year: GAAP SG&A was $352.7 million, 33.0% of revenues, versus $514.0 million (57.3%). Non-GAAP SG&A was $308.5 million versus $472.3 million, reflecting the prior-year Xyrem settlements, partly offset by higher compensation and Modeyso costs. Source
  • Operating cash flow of $408 million: Cash from operations was $408 million. Cash, cash equivalents and investments were $2.9 billion at March 31, 2026, against long-term debt principal of $5.4 billion. Source
  • Zanidatamab first-line GEA filing accepted: The sBLA for zanidatamab in first-line HER2+ GEA was accepted under RTOR with Priority Review. Management said potential approval and launch could come on or before the August 25, 2026 PDUFA date. Source

“Our first-quarter results reflect disciplined execution across the business, delivering 19% year-over-year growth alongside key pipeline advancements and positioning the company for an outstanding 2026”

Renee Gala, president and chief executive officer of Jazz Pharmaceuticals

Guidance

AreaPeriodFigureAgainst last quarter
Total revenues Sourcefull year 2026$4,250 - $4,500 millionKept
Gross margin (GAAP) Sourcefull year 202689% - 90%Kept
Gross margin (non-GAAP) Sourcefull year 202690% - 91%Kept
SG&A expenses (GAAP) Sourcefull year 2026$1,424 - $1,497 millionKept
R&D expenses (GAAP) Sourcefull year 2026$811 - $867 millionKept
R&D expenses (non-GAAP) Sourcefull year 2026$725 - $775 millionKept
Effective tax rate (GAAP) Sourcefull year 20260% - 10%Kept
Effective tax rate (non-GAAP) Sourcefull year 202611.5% - 13.5%Kept
Weighted-average ordinary shares outstanding Sourcefull year 202666 - 67 millionRaised from 65 - 66 million

What changed from last quarter

  • Guidance raised: Weighted-average ordinary shares outstanding guidance raised to 66 to 67 million from 65 to 66 million; all other 2026 guidance reaffirmed. Source
  • New: Zanidatamab sBLA for HER2+ first-line GEA accepted with Priority Review under RTOR, PDUFA date August 25, 2026. Prior release expected sBLA completion in 1Q26. Source
  • New: Company completed sale of its Rare Pediatric Disease Priority Review Voucher for $200 million gross, 50% to Jazz. Source
  • New: Agreement with Nippon Zoki to commercialize Epidyolex in Japan, following ongoing clinical trials and potential regulatory approval. Source

Results and growth drivers

  • Revenue grew 19% year over year: Total revenues were $1,068.9 million versus $897.8 million, up 19%, driven by Xywav, Zepzelca and Epidiolex/Epidyolex net product sales and the inclusion of Modeyso. Source
  • GAAP EPS positive after prior-year loss: GAAP diluted EPS was $4.43 versus a loss of $1.52 a year earlier; non-GAAP adjusted diluted EPS was $6.34 versus $1.68. The GAAP result included a $122.8 million gain on the PRV sale. Source
  • Prior-year Xyrem settlements affected comparison: The 1Q25 GAAP and non-GAAP results included a $172 million Xyrem antitrust litigation settlement expense, which lowered SG&A in the current quarter versus the prior-year period. Source

Segments and regions

  • Sleep franchise revenue up 15%: Sleep revenue was $439.4 million, up from $382.0 million, with Xywav at $408.2 million and Xyrem at $31.2 million. Source
  • Epilepsy franchise revenue up 15%: Epidiolex/Epidyolex net product sales were $249.8 million, up from $217.7 million, driven by continued demand. Source
  • Oncology revenue up 45%: Oncology product sales were $333.4 million versus $229.4 million, with Modeyso, Zepzelca and Ziihera contributing alongside Rylaze, Defitelio and Vyxeos. Source
  • High-sodium oxybate royalties declined: High-sodium oxybate authorized generic royalty revenue was $36.3 million, down from $48.9 million. Source

“Demand for Xywav remained strong, our rare oncology launches with Modeyso™ and Zepzelca ® in 1LM ES-SCLC gained significant momentum, and Epidiolex continued to provide consistent growth.”

Renee Gala, president and chief executive officer of Jazz Pharmaceuticals

Products and customers

  • Xywav added 425 net patients: Xywav net product sales rose 18% to $408 million. Approximately 16,600 active patients exited the quarter, of whom about 11,075 had narcolepsy and 5,525 idiopathic hypersomnia. Source
  • Zepzelca growth from first-line use: Zepzelca sales rose 60% to $101 million, driven by the first-line maintenance combination with atezolizumab, partly offset by lower second-line use, which management expects to decline through the year. Source
  • Modeyso launch continues: Modeyso net product sales were $41 million, with about 500 patients having received the drug from launch in August 2025 through the end of the first quarter. Source
  • Ziihera biliary tract sales: Ziihera net product sales in biliary tract cancer were $13 million, compared with $2 million a year earlier. Source

Costs, margins and pricing

  • GAAP gross margin slightly lower: GAAP gross margin on total revenues was 87.5% versus 88.3%; non-GAAP adjusted was 91.6% versus 92.2%. Cost of product sales rose on higher royalty expense and inventory provisions. Source
  • SG&A fell sharply year over year: GAAP SG&A was $352.7 million, 33.0% of revenues, versus $514.0 million (57.3%). Non-GAAP SG&A was $308.5 million versus $472.3 million, reflecting the prior-year Xyrem settlements, partly offset by higher compensation and Modeyso costs. Source
  • R&D spend rose on Modeyso: GAAP R&D was $196.0 million versus $180.7 million; non-GAAP R&D was $172.3 million versus $159.7 million, reflecting Modeyso costs including personnel. Source
  • Tax rate low on PRV gain: GAAP effective tax rate was 2.0% versus 16.2%, with the GAAP tax expense mainly attributable to the PRV gain, partly offset by excess share-based compensation tax benefits. Non-GAAP effective rate was 8.9% versus 25.7%. Source

Cash, balance sheet and capital

  • Operating cash flow of $408 million: Cash from operations was $408 million. Cash, cash equivalents and investments were $2.9 billion at March 31, 2026, against long-term debt principal of $5.4 billion. Source
  • Undrawn revolver of $885 million: The company had $885 million of undrawn borrowing capacity under its revolving credit facility at quarter end. Source
  • PRV sale proceeds received: The company received $200 million gross proceeds from the PRV sale, 50% attributable to Jazz. Source

Strategy, pipeline and regulatory

  • Zanidatamab first-line GEA filing accepted: The sBLA for zanidatamab in first-line HER2+ GEA was accepted under RTOR with Priority Review. Management said potential approval and launch could come on or before the August 25, 2026 PDUFA date. Source
  • HERIZON-GEA-01 data published and submitted: HERIZON-GEA-01 data were accepted for publication in a top-tier medical journal and submitted for potential NCCN guideline inclusion. Source
  • Modeyso Phase 3 readout timing: The Phase 3 ACTION trial of Modeyso remains on track, with top-line readout expected late 2026 or early 2027. Source
  • Japan Epidyolex partnership: An agreement with Nippon Zoki was announced to commercialize Epidyolex in Japan, following ongoing clinical trials and potential regulatory approval. Source

Coming up, as management said on 5 May 2026

  • Zanidatamab first-line GEA PDUFA date: FDA decision on the zanidatamab sBLA for first-line HER2+ GEA is due August 25, 2026, with potential launch on or before that date. Source
  • Second interim OS analysis mid-2026: The second interim overall survival analysis for the HERIZON-GEA-01 doublet regimen is expected in mid-2026. Source
  • Modeyso ACTION top-line readout: Top-line data from the Phase 3 ACTION trial of Modeyso are expected late 2026 or early 2027. Source

Risks management discussed

  • Demand: Second-line Zepzelca use is declining, and maintaining or increasing sales of Xywav, Epidiolex, Ziihera, Modeyso and Zepzelca is an identified risk. Source

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.