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Jazz Pharmaceuticals plc: Q2 FY2026 earnings call

What management said about Q2 FY2026, from the documents filed with the SEC on 3 August 2026: press release. Guidance figures: 4 raised, 1 new, 6 kept. The quarter’s numbers.

Key takeaways

  • Record quarterly revenue, up 16%: Total revenues were $1,208.3 million in 2Q26, up from $1,045.7 million, with Xywav, Epidiolex/Epidyolex, Zepzelca and Modeyso net product sales the main contributors. Source
  • Diluted EPS swung to profit: GAAP diluted EPS was $2.78 versus a loss of $11.74 a year earlier; non-GAAP adjusted diluted EPS was $5.71 versus a loss of $8.25. The prior-year quarter included $905.4 million of acquired IPR&D. Source
  • Xywav grew 13%: Xywav net product sales were $471.2 million, up 13% from $415.3 million, with about 525 net patient adds and about 17,125 active patients at quarter end. Source
  • Zanidatamab 1L GEA decision due: FDA granted Priority Review for zanidatamab in first-line HER2-positive GEA with a PDUFA date of August 25, 2026; the company says it is prepared to launch immediately after approval. Source
  • Zepzelca second-line label change: Following LAGOON results and alignment with FDA, the company will submit a labeling supplement in 3Q26 to remove the second-line indication; first-line maintenance is not affected. Source
  • Acquired IPR&D charge of $77.0 million: Acquired IPR&D of $77.0 million covered upfront payments to AbCellera and Werewolf, reducing net income by $65.4 million or $0.94 per share. Source
  • Cash from operations $824 million: The company generated $824 million of cash from operations in the first half of 2026, against $518.6 million in the same period of 2025. Source
  • Debt reduced by $1.0 billion repayment: The company repaid $1.0 billion of 2.00% exchangeable senior notes due 2026 in June 2026; long-term debt principal was $4.4 billion at quarter end. Source
  • Zanidatamab approval decision in August: The PDUFA target date for zanidatamab in 1L HER2-positive GEA is August 25, 2026, and the company said it is prepared to launch immediately after approval. Source

“Our second quarter results highlight strong execution and momentum across the business, delivering 16% year-over-year total revenue growth and driving a considerable increase to our full-year revenue guidance,”

Renee Gala, president and chief executive officer of Jazz Pharmaceuticals

Guidance

AreaPeriodFigureAgainst last quarter
Total revenues Sourcefull year 2026$4,600 - $4,750 millionRaised from $4,250 - $4,500 million
GAAP gross margin Sourcefull year 202689% - 90%Kept
GAAP SG&A expenses Sourcefull year 2026$1,506 - $1,556 millionRaised from $1,424 - $1,497 million
GAAP R&D expenses Sourcefull year 2026$818 - $873 millionRaised from $811 - $867 million
GAAP effective tax rate Sourcefull year 20260% - 10%Kept
Weighted-average diluted shares outstanding Sourcefull year 202669 - 70 millionRaised from 66 - 67 million
Non-GAAP gross margin Sourcefull year 202690% - 91%Kept
Non-GAAP effective tax rate Sourcefull year 202611.5% - 13.5%Kept
Zanidatamab HER2+ 1L GEA FDA action SourcePDUFA target dateAugust 25, 2026Kept
HERIZON-GEA-01 second interim OS readout Sourcethird quarter of 2026Top-line results expected in 3Q26Kept
Modeyso ACTION trial OS interim analysis Sourcefirst half of 20271H27New

What changed from last quarter

  • Guidance raised: Full-year 2026 total revenue guidance raised to $4,600 - $4,750 million from $4,250 - $4,500 million. Source
  • Guidance raised: GAAP SG&A, GAAP R&D, non-GAAP SG&A and weighted-average diluted share guidance increased. Source
  • New: Zepzelca second-line indication to be removed by labeling supplement, after LAGOON trial results and alignment with FDA; first-line maintenance unaffected. Source
  • New: Preclinical research collaboration with AbCellera announced for T-cell engaging multispecific antibodies; upfront payments made. Source
  • New: Asset purchase agreement to acquire remaining rights for JZP898 from Werewolf Therapeutics. Source
  • New: FDA granted Breakthrough Therapy designation for zanidatamab in previously treated HER2-positive colorectal cancer. Source
  • New: NDA submitted for a cannabidiol capsule formulation. Source
  • New: Epidiolex development program expanded with a Phase 3 DEE trial, a Phase 2/3 JME trial and a Phase 3b/4 adult LGS trial. Source

Results and growth drivers

  • Record quarterly revenue, up 16%: Total revenues were $1,208.3 million in 2Q26, up from $1,045.7 million, with Xywav, Epidiolex/Epidyolex, Zepzelca and Modeyso net product sales the main contributors. Source
  • Diluted EPS swung to profit: GAAP diluted EPS was $2.78 versus a loss of $11.74 a year earlier; non-GAAP adjusted diluted EPS was $5.71 versus a loss of $8.25. The prior-year quarter included $905.4 million of acquired IPR&D. Source

Segments and product revenues

  • Xywav grew 13%: Xywav net product sales were $471.2 million, up 13% from $415.3 million, with about 525 net patient adds and about 17,125 active patients at quarter end. Source
  • Epidiolex grew 16%: Epidiolex/Epidyolex net product sales were $292.1 million, up from $251.7 million, driven by what management called continued strong demand. Source
  • Zepzelca rose 42%: Zepzelca net product sales were $105.8 million, up from $74.5 million, on first-line maintenance uptake with atezolizumab, partly offset by lower second-line use. Source
  • Modeyso and Ziihera sales: Modeyso net product sales were $48.2 million, with more than 600 patients treated since August 2025 launch; Ziihera BTC sales were $15.4 million. Source
  • Royalty revenue declined: High-sodium oxybate AG royalty revenue fell to $42.2 million from $54.1 million, and Xyrem net product sales fell to $30.5 million from $35.4 million. Source

“We remain focused on long-term growth as we prepare to launch Ziihera in HER2+ 1L GEA, advance the zanidatamab and Epidiolex clinical programs, and expand our pipeline through targeted corporate development and internal research and development.”

Renee Gala, president and chief executive officer of Jazz Pharmaceuticals

Products, pipeline and customers

  • Zanidatamab 1L GEA decision due: FDA granted Priority Review for zanidatamab in first-line HER2-positive GEA with a PDUFA date of August 25, 2026; the company says it is prepared to launch immediately after approval. Source
  • HERIZON data published and presented: Phase 3 HERIZON-GEA-01 results were published in the New England Journal of Medicine, and subgroup analyses presented at ASCO 2026 showed improved outcomes regardless of PD-L1 expression. Source
  • Zepzelca second-line label change: Following LAGOON results and alignment with FDA, the company will submit a labeling supplement in 3Q26 to remove the second-line indication; first-line maintenance is not affected. Source
  • AbCellera collaboration and Werewolf rights: A preclinical collaboration with AbCellera was announced, and an asset purchase agreement to acquire remaining JZP898 rights from Werewolf was signed; both upfronts were expensed as acquired IPR&D. Source

Costs, margins and tax

  • Gross margin narrowed slightly: GAAP gross margin on total revenues was 90.4%, against 88.9% a year earlier; non-GAAP adjusted gross margin was 92.1%, against 92.7%, as cost of product sales rose on higher royalty expense. Source
  • SG&A rose on marketing spend: GAAP SG&A was $389.2 million, or 32.2% of revenues, up from $358.4 million, primarily from higher marketing investment and compensation-related expenses. Source
  • R&D rose on zanidatamab trials: GAAP R&D was $207.5 million, or 17.2% of revenues, up from $189.9 million, driven by higher clinical study costs mainly for zanidatamab. Source
  • Acquired IPR&D charge of $77.0 million: Acquired IPR&D of $77.0 million covered upfront payments to AbCellera and Werewolf, reducing net income by $65.4 million or $0.94 per share. Source
  • Effective tax rate rose: GAAP effective tax rate was 8.6% against 2.3% a year earlier; the company attributed the change to shifts in the geographic mix of income and expenses. Source

Cash, debt and balance sheet

  • Cash from operations $824 million: The company generated $824 million of cash from operations in the first half of 2026, against $518.6 million in the same period of 2025. Source
  • Debt reduced by $1.0 billion repayment: The company repaid $1.0 billion of 2.00% exchangeable senior notes due 2026 in June 2026; long-term debt principal was $4.4 billion at quarter end. Source
  • Liquidity position: Cash, cash equivalents and investments totaled $2.2 billion at June 30, 2026, down from $2.9 billion at March 31, with $885 million of undrawn revolving credit capacity. Source

Strategy and business development

  • Portfolio expansion through deals and R&D: Management said the company will expand its pipeline through targeted corporate development and internal research and development, and continues to evaluate additional value-enhancing corporate development. Source
  • Epidiolex and zanidatamab trial expansion: The Epidiolex program added Phase 3 DEE, Phase 2/3 JME and Phase 3b/4 adult LGS trials; an NDA for a cannabidiol capsule was submitted; zanidatamab registrational work continues in other tumors. Source

Pipeline milestones ahead

  • Zanidatamab approval decision in August: The PDUFA target date for zanidatamab in 1L HER2-positive GEA is August 25, 2026, and the company said it is prepared to launch immediately after approval. Source
  • Second interim OS data in 3Q26: Top-line results from the second interim overall survival analysis of the HERIZON-GEA-01 doublet regimen are expected in 3Q26. Source
  • Modeyso OS interim timing: The OS interim analysis of the Phase 3 ACTION trial is anticipated in 1H27, based on current pace of event accrual. Source

Coming up, as management said on 3 August 2026

  • Zanidatamab FDA decision: PDUFA target action date for zanidatamab in 1L HER2+ GEA is August 25, 2026, with launch planned immediately after approval. Source
  • Second interim OS readout: Top-line results from the HERIZON-GEA-01 second interim overall survival analysis are expected in 3Q26. Source
  • Zepzelca labeling supplement: A labeling supplement to remove the second-line indication is to be submitted to FDA in 3Q26. Source
  • Modeyso ACTION interim analysis: The OS interim analysis of the Phase 3 ACTION trial is anticipated in 1H27. Source

Risks management discussed

  • Demand: Zepzelca second-line use declined, partly offsetting first-line growth; the company is removing the second-line indication. Source
  • Financial: Maintaining adequate coverage and reimbursement for products is a stated risk; the cost of product sales rose on higher royalty expense tied to Modeyso and Zepzelca revenue. Source

Earlier plans management reported on

  • On track: The company said it is prepared to launch zanidatamab in HER2+ 1L GEA immediately following FDA approval, with the PDUFA date unchanged at August 25, 2026. Source
  • Delayed: The 1Q26 release said the second interim OS analysis was expected in mid-2026; the 2Q26 release now expects top-line results in 3Q26. Source
  • Delayed: The 1Q26 release expected top-line readout in late 2026 / early 2027; the 2Q26 release now anticipates the OS interim analysis in 1H27. 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.