Jazz Pharmaceuticals plc (JAZZ): Results of Operations and Financial Condition
Jazz Pharmaceuticals plc (JAZZ) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Jazz Pharmaceuticals Announces Second Quarter 2026 Financial Results – Continued commercial execution drives record total revenues of $1.2 billion (+16% YoY) – – Company raises 2026 revenue guidance – – Prepared to launch Ziihera ® in HER2+ 1L GEA immediately followi
How this was made
The 30-second read
Why it matters
The combination of a same-day guidance raise, record quarterly revenues, and a specific FDA PDUFA date for zanidatamab sBLA creates a clear near-term catalyst path for earnings expectations and risk premium.
Market read
Traders can reprice JAZZ based on the raised 2026 revenue guidance and the defined FDA timeline for zanidatamab sBLA, alongside updated product sales momentum.
What to watch
The filing notes planned Zepzelca labeling supplement to remove the second-line indication in 3Q26, which could temper longer-term revenue expectations even as first-line maintenance remains unaffected.
Continued commercial execution drives record total revenues of $1.2 billion (+16% YoY); company raises 2026 revenue guidance.
Record total revenues grew 16% YoY, led by growth in Xywav, Epidiolex/Epidyolex and Zepzelca and the inclusion of Modeyso. The company raised full-year total revenue guidance to $4,600 - $4,750 million while reporting positive GAAP and non-GAAP adjusted earnings per share.
Actuals vs. the company’s prior outlook
from its previous release| Metric | Guided | Reported | Verdict |
|---|---|---|---|
| Total Revenues | $4,250 - $4,500 million | Not reported for full-year 2026 | n/a |
| GAAP gross margin % | 89% - 90% | Not reported for full-year 2026 | n/a |
| GAAP SG&A expenses | $1,424 - $1,497 million | Not reported for full-year 2026 | n/a |
| GAAP R&D expenses | $811 - $867 million | Not reported for full-year 2026 | n/a |
| GAAP effective tax rate | 0% - 10% | Not reported for full-year 2026 | n/a |
| GAAP weighted-average diluted shares outstanding | 66 - 67 | Not reported for full-year 2026 | n/a |
| Non-GAAP adjusted gross margin % | 90% - 91% | Not reported for full-year 2026 | n/a |
| Non-GAAP adjusted SG&A expenses | $1,260 - $1,320 million | Not reported for full-year 2026 | n/a |
| Non-GAAP adjusted R&D expenses | $725 - $775 million | Not reported for full-year 2026 | n/a |
| Non-GAAP adjusted effective tax rate | 11.5% - 13.5% | Not reported for full-year 2026 | n/a |
| Non-GAAP adjusted weighted-average diluted shares outstanding | 66 - 67 | Not reported for full-year 2026 | n/a |
Key metrics
as reported| Metric | Value | q/q | y/y |
|---|---|---|---|
| Total revenuesother | $1,208.3 million | – | 16% |
| Product sales, netother | $1,156.1 million | – | – |
| High-sodium oxybate AG royalty revenueother | $42.2 million | – | – |
| Other royalty and contract revenuesother | $10.0 million | – | – |
| GAAP net income (loss)GAAP | $192.8 million | – | – |
| Non-GAAP adjusted net income (loss)non-GAAP | $396.4 million | – | – |
| GAAP earnings (loss) per shareGAAP | $2.78 | – | – |
| Non-GAAP adjusted earnings (loss) per sharenon-GAAP | $5.71 | – | – |
| GAAP cost of product salesGAAP | $116.4 million | – | – |
| GAAP gross margin on total revenuesGAAP | 90.4% | – | – |
| GAAP selling, general and administrativeGAAP | $389.2 million | – | – |
| GAAP selling, general and administrative as percentage of total revenuesGAAP | 32.2% | – | – |
| GAAP research and developmentGAAP | $207.5 million | – | – |
| GAAP research and development as percentage of total revenuesGAAP | 17.2% | – | – |
| GAAP acquired in-process research and developmentGAAP | $77.0 million | – | – |
| GAAP income tax expense (benefit)GAAP | $18.1 million | – | – |
| GAAP effective tax rateGAAP | 8.6% | – | – |
| Non-GAAP adjusted cost of product salesnon-GAAP | $95.1 million | – | – |
| Non-GAAP adjusted gross margin on total revenuesnon-GAAP | 92.1% | – | – |
| Non-GAAP adjusted selling, general and administrativenon-GAAP | $343.2 million | – | – |
| Non-GAAP adjusted selling, general and administrative as percentage of total revenuesnon-GAAP | 28.4% | – | – |
| Non-GAAP adjusted research and developmentnon-GAAP | $184.9 million | – | – |
| Non-GAAP adjusted research and development as percentage of total revenuesnon-GAAP | 15.3% | – | – |
| Non-GAAP adjusted acquired in-process research and developmentnon-GAAP | $77.0 million | – | – |
| Non-GAAP adjusted income tax expensenon-GAAP | $74.4 million | – | – |
| Non-GAAP adjusted effective tax ratenon-GAAP | 15.8% | – | – |
Segments
| Segment | Revenue | q/q | y/y |
|---|---|---|---|
| XywavRobust new patient growth and continued physician and patient demand for the differentiated benefits of low-sodium Xywav. | $471.2 million | – | 13% |
| XyremNot stated. | $30.5 million | – | – |
| SleepNot stated. | $501.7 million | – | – |
| Epidiolex/EpidyolexContinued strong demand. | $292.1 million | – | 16% |
| EpilepsyNot stated. | $292.1 million | – | – |
| ZepzelcaContinued uptake of the Zepzelca and atezolizumab combination in the 1L maintenance ES-SCLC setting, partially offset by a decline in second-line use. | $105.8 million | – | 42% |
| Rylaze/EnrylazeNot stated. | $99.5 million | – | – |
| Defitelio/defibrotideNot stated. | $62.0 million | – | – |
| ModeysoModeyso net product sales were included following FDA approval in August 2025. | $48.2 million | – | – |
| VyxeosNot stated. | $31.4 million | – | – |
| ZiiheraNet product sales in biliary tract cancer. | $15.4 million | – | – |
| OncologyNot stated. | $362.3 million | – | – |
Full-year 2026 outlook
- Revenue$4,600 - $4,750 million
- Gross marginGAAP: 89% - 90%; Non-GAAP adjusted: 90% - 91%
- Tax rateGAAP: 0% - 10%; Non-GAAP adjusted: 11.5% - 13.5%
- NoteGAAP SG&A expenses: $1,506 - $1,556 million
- NoteGAAP R&D expenses: $818 - $873 million
- NoteGAAP weighted-average diluted shares outstanding: 69 - 70
- NoteNon-GAAP adjusted SG&A expenses: $1,330 - $1,370 million
- NoteNon-GAAP adjusted R&D expenses: $725 - $775 million
- NoteNon-GAAP adjusted weighted-average diluted shares outstanding: 69 - 70
What drove it
- Total revenues increased 16% in 2Q26 YoY primarily due to higher Xywav, Epidiolex/Epidyolex and Zepzelca net product sales and the inclusion of Modeyso net product sales, following FDA approval in August 2025.
- Xywav had approximately 525 net patient adds in 2Q26 and approximately 17,125 active patients exiting the quarter.
- Cost of product sales increased on a GAAP and non-GAAP adjusted basis primarily due to higher royalty expenses driven by higher revenues of Modeyso and Zepzelca.
- SG&A increased on a GAAP and non-GAAP adjusted basis primarily due to higher marketing investment and compensation-related expenses in support of the commercial portfolio.
- R&D increased on a GAAP and non-GAAP adjusted basis due to higher clinical studies costs, primarily related to zanidatamab.
Concerns
- Zepzelca growth from the 1L maintenance ES-SCLC setting was partially offset by a decline in second-line use.
- The company plans in 3Q26 to submit a labeling supplement to remove the second-line indication for Zepzelca.
- GAAP and non-GAAP adjusted results included $77.0 million of acquired IPR&D expense relating to upfront payments connected with AbCellera and Werewolf.
- Long-term debt was $4.4 billion as of June 30, 2026.
What to watch
- FDA PDUFA target action date of August 25, 2026 for the sBLA for zanidatamab-containing combinations in 1L GEA.
- Top-line results from the second interim OS analysis for the HERIZON-GEA-01 trial doublet regimen expected in 3Q26.
- FDA review and subsequent action on the planned Zepzelca labeling supplement in 3Q26.
- OS interim analysis for the event-driven Phase 3 ACTION trial anticipated in 1H27, based on the current pace of event accrual.
- Execution against full-year 2026 total revenue guidance of $4,600 - $4,750 million.
Balance sheet and cash flow
- As of June 30, 2026, cash, cash equivalents and investments were $2.2 billion.
- The outstanding principal balance of the company’s long-term debt was $4.4 billion.
- The company had undrawn borrowing capacity under a revolving credit facility of $885 million.
- In June 2026, we repaid the $1.0 billion aggregate principal amount of the 2.00% exchangeable senior notes due 2026.
- For the six months ended June 30, 2026, the company generated $824 million of cash from operations.
Analysis
Jazz reported its highest ever total quarterly revenues, with $1,208.3 million in 2Q26, up 16% from $1,045.7 million in 2Q25. Management attributed the increase primarily to higher Xywav, Epidiolex/Epidyolex and Zepzelca net product sales, plus Modeyso sales following its FDA approval in August 2025. GAAP net income was $192.8 million and non-GAAP adjusted net income was $396.4 million, compared with GAAP and non-GAAP adjusted net losses in 2Q25 that included $905.4 million of acquired IPR&D expense related to the Chimerix Acquisition.
The sleep franchise generated $501.7 million, including $471.2 million from Xywav. Xywav sales rose 13% YoY, supported by approximately 525 net patient adds and approximately 17,125 active patients exiting the quarter. Epilepsy revenue was $292.1 million, with Epidiolex/Epidyolex sales increasing 16% YoY on continued strong demand. Oncology revenue was $362.3 million. Zepzelca grew 42% YoY to $105.8 million on first-line maintenance uptake, while Modeyso contributed $48.2 million and Ziihera contributed $15.4 million.
GAAP gross margin on total revenues was 90.4%, versus 88.9% in 2Q25, while non-GAAP adjusted gross margin was 92.1%, versus 92.7%. GAAP SG&A and R&D increased to $389.2 million and $207.5 million, respectively, although their percentages of total revenues declined to 32.2% and 17.2%. The quarter included $77.0 million of acquired IPR&D expenses tied to upfront payments for the AbCellera collaboration and the purchase of remaining rights for JZP898 from Werewolf.
The company reported $824 million of cash from operations for the six months ended June 30, 2026. Cash, cash equivalents and investments were $2.2 billion, long-term debt was $4.4 billion, and Jazz repaid $1.0 billion of exchangeable senior notes in June 2026. The updated revenue guide of $4,600 - $4,750 million is above the prior $4,250 - $4,500 million range. The guide retains both GAAP and non-GAAP adjusted gross-margin ranges, while increasing SG&A expense ranges and weighted-average diluted share assumptions.
Near-term execution centers on the August 25, 2026 PDUFA target action date for zanidatamab in 1L GEA, anticipated HERIZON-GEA-01 doublet OS data in 3Q26, and the planned Zepzelca labeling supplement that would remove its second-line indication. The filing states that the first-line maintenance indication will not be affected. Development spending is rising primarily because of zanidatamab clinical studies, alongside expanded Epidiolex trials and the newly announced AbCellera research collaboration.
Management, verbatim
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
Not in the filing
stated, not guessed- GAAP operating income
- Non-GAAP adjusted operating income
- Free cash flow
- Share repurchases
- Dividends
- Quarter-over-quarter comparisons for reported metrics
- Full-year 2026 actual results needed to assess performance against prior full-year guidance
- Weighted-average diluted shares outstanding for 2Q26
- Individual product year-over-year percentage changes where not expressly reported
AlphaAI analysis generated from the company’s SEC earnings filing (Form 8-K Item 2.02, or Form 6-K for a foreign private issuer). Every figure was cross-checked against the filing text; consensus estimates, price targets and share-price reactions are not shown because they are not in the filing. AI-generated research, not investment advice.
Background
This SEC 8-K item 2.02 attaches Jazz’s 2Q26 financial results and business updates, including FDA regulatory timelines and guidance.
Ticker impact
Jazz reported 2Q26 results and raised 2026 revenue guidance to $4.60 to $4.75 billion, citing strong Xywav and Epidiolex growth.
Likely positive bias for the stock into the Aug 25, 2026 PDUFA date and as investors model the raised 2026 revenue range.
The filing includes concrete financial datapoints (2Q26 revenue, EPS, cash from operations) and a specific guidance increase, plus a scheduled FDA action date for zanidatamab sBLA and a planned Ziihera launch immediately after approval.
Market effects
Reinforces demand momentum in specialty pharma neurology and epilepsy franchises, potentially supporting sentiment for peers with similar commercial execution.
Primarily US-focused due to FDA action date and US commercial metrics, with limited direct regional spillover.
Modest global read-through, as the catalysts are US regulatory and US revenue drivers.
Counterpoint
Raised guidance may already be partially anticipated; investors could focus on the smaller near-term Ziihera revenue base ($15M BTC sales) versus the larger upside implied by future HER2+ 1L launch.
Key entities
- issuerJazz Pharmaceuticals plc
Reported 2Q26 financial results, raised 2026 revenue guidance, and provided FDA and launch timing for Ziihera (zanidatamab).
- product_programZiihera (zanidatamab-hrii)
Prepared to launch in HER2+ 1L GEA immediately following FDA approval, with PDUFA target action date of Aug 25, 2026.
- productXywav (calcium, magnesium, potassium, and sodium oxybates)
2Q26 net product sales grew 13% YoY to $471M with ~525 net patient adds.
- productEpidiolex/Epidyolex (cannabidiol)
2Q26 net product sales grew 16% YoY to $292M, with expanded development program and NDA submission for capsule formulation.
- product_programZepzelca (lurbinectedin)
2Q26 net product sales increased 42% YoY to $106M; company plans a labeling supplement in 3Q26 to remove second-line indication.
