JAZZ

Expanded safety, subgroup, progression-free survival sensitivity and subsequent therapy analyses further characterize the consistency and durability of outcomes observed with zanidatamab-containing combinations in the first-line setting Additional subgroup analyses to be presented at the 2026 ASCO Annual Meeting show improved clinical outcomes with zanidatamab-containing combinations regardless of PD-L1 expression, including in PD-L1-negative patients For U.S. media and investors only DUBLIN, May 27, 2026 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the New England Journal of Medicine has published the Phase 3 HERIZON-GEA-01 trial results, further characterizing the efficacy and safety profile of Ziihera® (zanidatamab-hrii) in combination with chemotherapy, with and without the PD-1 inhibitor Tevimbra® (tislelizumab), as first-line treatment for adults with HER2-positive (HER2+) locally advanced or metastatic gastroesophageal adenocarcinoma (GEA), including cancers of the stomach, gastroesophageal junction, and esophagus. The manuscript builds on the late-breaking oral presentation of the HERIZON-GEA-01 trial results at the 2026 ASCO Gastrointestinal Cancers Symposium (ASCO GI), where zanidatamab-containing combinations demonstrated unprecedented progression-free survival (PFS) and overall survival (OS) outcomes in a global Phase 3 trial. As previously reported, both zanidatamab-containing combinations significantly improved PFS compared with trastuzumab plus chemotherapy (median PFS 12.4 months versus 8.1 months; Hazard Ratio (HR) 0.63-0.65), and zanidatamab plus tislelizumab and chemotherapy demonstrated a statistically significant OS benefit (median OS 26.4 versus 19.2 months; HR 0.72). At the first interim analysis, zanidatamab plus chemotherapy also demonstrated a median OS of more than two years. The OS for zanidatamab plus chemotherapy will be assessed at a second interim analysis expected in mid-2026. The publication includes expanded prespecified subgroup analyses showing that PFS and OS results were generally consistent across clinically relevant patient characteristics, including PD-L1 status, geographic region, and Eastern Cooperative Oncology Group performance status, as well as PFS sensitivity analyses supporting the robustness of the findings. Expanded safety analyses further characterize the safety profile of z...

Jazz Pharmaceuticals delivered a first quarter that was met with a positive response from the market, driven largely by strong commercial execution across its sleep, epilepsy, and oncology franchises. Management credited the performance to robust demand for Xywav, Epidiolex, Midevo, and Zepzelca, with CEO Renée Galá highlighting, “Our commercial teams generated double-digit growth across all our promoted brands, and saw strong contributions from our ongoing launches.” The company’s focus on differentiated patient support and broadening market penetration for both new and established therapies contributed to the notable revenue growth observed this quarter. Is now the time to buy JAZZ? Find out in our full research report (it’s free). Revenue: $1.07 billion vs analyst estimates of $977.1 million (19.1% year-on-year growth, 9.4% beat) Adjusted EPS: $6.34 vs analyst estimates of $4.66 (36.2% beat) Adjusted EBITDA: $507.2 million vs analyst estimates of $393.3 million (47.5% margin, 29% beat) The company reconfirmed its revenue guidance for the full year of $4.38 billion at the midpoint Operating Margin: 31.5%, up from -6.2% in the same quarter last year Market Capitalization: $14.03 billion While we enjoy listening to the management's commentary, our favorite part of earnings calls are the analyst questions. Those are unscripted and can often highlight topics that management teams would rather avoid or topics where the answer is complicated. Here is what has caught our attention. Jessica Macomber Fye (JPMorgan) asked about the sequencing and positioning of zanidatumab in breast cancer post-ENHERTU. Chief Medical Officer Robert Iannone explained their trial is designed to provide definitive data, aiming to inform physician decisions in a space with little available evidence after ENHERTU. Joseph John-Charles Thome (TD Cowen) inquired about the addressable patient population for Midevo and the company’s M&A strategy. Chief Commercial Officer Samantha Pearce discussed longer-than-expected treatment durations and potential population upside, while CEO Renée Galá emphasized a focus on rare disease expansion and financial readiness to pursue deals. Leonid Timashev (RBC) asked about Jazz Pharmaceuticals’ approach to epilepsy market expansion and potential cannibalization. Galá cited persistent unmet need, the durability of Epidiolex’s franchise, and ongoing investment...

Jazz Pharmaceuticals (NASDAQ:JAZZ) is one of the best healthcare stocks to buy for the long term. Jazz Pharmaceuticals (NASDAQ:JAZZ) received several rating updates following the release of financial results for fiscal Q1 2026 on May 5, where it reported strong commercial execution across franchises with total revenues of $1.1 billion, up 19% year-over-year. Raymond James lifted the price target on Jazz Pharmaceuticals (NASDAQ:JAZZ) to $239 from $227 on May 7, reaffirming an Outperform rating on the shares. The firm told investors in a research note that the company is up 25% year-to-date, with investors beginning to understand that Jazz Pharmaceuticals (NASDAQ:JAZZ) is in the early innings of a transformation from a spec pharma story to an innovation-led biotech story. This holds especially true following Zani’s highly competitive readout in 1L GEA and priority review, according to the firm. Jazz Pharmaceuticals (NASDAQ:JAZZ) also received a rating update from TD Cowen the same day, with the firm lifting the price target on the stock to $275 from $220 and maintaining a Buy rating on the shares. Jazz Pharmaceuticals (NASDAQ:JAZZ) develops medicines for serious diseases. Its primary marketed products include Xywav, Xyrem oral solution, Epidiolex oral solution, Rylaze, Zepzelca, Defitelio, and Vyxeos liposome for injection. These medicines treat excess daytime sleepiness (EDS) in narcolepsy patients seven years of age or older, tepatic veno-occlusive disease (VOD), and other ailments. While we acknowledge the potential of JAZZ as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 15 Stocks That Will Make You Rich in 10 Years AND 12 Best Stocks That Will Always Grow. Disclosure: None. Follow Insider Monkey on Google News.

Jazz Pharmaceuticals plc's (NASDAQ:JAZZ) recent soft profit numbers didn't appear to worry shareholders, as the stock price showed strength. We think that investors might be looking at some positive factors beyond the earnings numbers. This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality. One key financial ratio used to measure how well a company converts its profit to free cash flow (FCF) is the accrual ratio. To get the accrual ratio we first subtract FCF from profit for a period, and then divide that number by the average operating assets for the period. This ratio tells us how much of a company's profit is not backed by free cashflow. As a result, a negative accrual ratio is a positive for the company, and a positive accrual ratio is a negative. That is not intended to imply we should worry about a positive accrual ratio, but it's worth noting where the accrual ratio is rather high. Notably, there is some academic evidence that suggests that a high accrual ratio is a bad sign for near-term profits, generally speaking. Jazz Pharmaceuticals has an accrual ratio of -0.16 for the year to March 2026. Therefore, its statutory earnings were very significantly less than its free cashflow. In fact, it had free cash flow of US$1.1b in the last year, which was a lot more than its statutory profit of US$29.5m. Jazz Pharmaceuticals' free cash flow actually declined over the last year, which is disappointing, like non-biodegradable balloons. However, we can see that a recent tax benefit, along with unusual items, have impacted its statutory profit, and therefore its accrual ratio. See our latest analysis for Jazz Pharmaceuticals That might leave you wondering what analysts are forecasting in terms of future profitability. Luckily, you can click here to see an interactive graph depicting future profitability, based on their estimates. Jazz Pharmaceuticals' profit was reduced by unusual items worth US$1.5b in the last twelve months, and this helped it produce high cash conversion, as reflected by its unusual items. This is what you'd expect to see where a company has a non-cash charge reducing paper profits. It's never great to see unusual items costing the company profits, but on the upside, things might improve sooner rather than later. When we analysed the vast majority of listed companies worldwide, we found...

Achieved record first quarter total revenues of $1.1 billion, representing 19% year-over-year growth driven by double-digit performance across all promoted brands. Oncology portfolio growth of 45% was significantly bolstered by the rapid adoption of Zepzelca in the first-line maintenance setting following its FDA approval in October of the previous year. Xywav remains the leading branded narcolepsy treatment, with growth supported by its unique low-sodium profile and status as the only approved therapy for idiopathic hypersomnia. Management attributes the strong Epidiolex performance to 16% volume growth and successful expansion into the adult patient population and long-term care settings. The company is leveraging a 90% customer overlap between biliary tract cancer and gastric esophageal adenocarcinoma (GEA) to prepare for the anticipated Ziihera launch. Operational strength is underscored by $408 million in quarterly cash flow, providing flexibility for disciplined capital allocation and targeted business development in rare diseases. Reaffirmed full-year 2026 revenue guidance of $4.25 billion to $4.5 billion, assuming increased competitive dynamics in the sleep business during the second half of the year, including a decline in Xyrem and high-sodium authorized generic revenues as generic volumes build. Anticipates FDA approval and launch of Ziihera in GEA on or before the August 25, 2026, PDUFA date, following priority review designation. Expects a second interim analysis for overall survival from the HERIZON-GEA trial mid-2026 to further validate zanidatamab's clinical benefit. The confirmatory ACTION trial for Modeyso is projected to reach an interim overall survival readout by late 2026 or early 2027 to support potential first-line regulatory approval. Long-term pipeline milestones include top-line data from the EmpowHER trial in metastatic breast cancer expected in late 2027 or early 2028. Guidance accounts for the expected entry of high-sodium generics and new daytime wake-promoting agents in the narcolepsy market in the second half of 2026. Management expects a decline in second-line Zepzelca use as the market shifts toward first-line maintenance and competition increases. Gross margin was slightly impacted by a higher mix of royalty-bearing products, specifically Zepzelca and Modeyso. The company has initiated patent litigation against five ANDA f...

Jazz Pharmaceuticals JAZZ reported first-quarter 2026 adjusted earnings per share (EPS) of $6.34, which beat the Zacks Consensus Estimate of $4.67. In the year-ago quarter, the company posted EPS of $1.68, which was significantly impacted by higher operating expenses. Total revenues rose 19% year over year to $1.07 billion, which beat the Zacks Consensus Estimate of $972 million. Shares of Jazz edged higher in after-hours trading yesterday, likely driven by the stronger-than-expected earnings performance. The stock also continued to rise in pre-market trading today. Year to date, Jazz stock has gained 25% against the industry’s 2% decline. Image Source: Zacks Investment Research Net product sales increased 22% year over year to $1.03 billion. The reported figure beat both the Zacks Consensus Estimate of $925 million and our model estimate of $924 million. Jazz recorded $36.3 million in royalty revenues from high-sodium oxybate authorized generic (AG), down about 26% year over year. Other royalties and contract revenues declined 23% to $7.3 million. Net product sales for the combined oxybate business (Xyrem + Xywav) rose 15% to $439.4 million. This combined figure beat both the Zacks Consensus Estimate of $390 million and our model estimates of $393 million. Sales of the sleep disorder drug Xyrem declined 16% year over year to $31.2 million due to patients switching to Xywav and the launch of AGs in 2023. Xywav, a low-sodium formulation of Xyrem, recorded sales of $408.2 million in the quarter, up 18%. This upside can be attributed to the encouraging uptake of the drug in narcolepsy and idiopathic hypersomnia indications. This drug is currently Jazz’s most extensive product by net sales. Sales of the epilepsy drug Epidiolex/Epidyolex rose 15% to $249.8 million, driven by continued strong demand. This metric also beat the Zacks Consensus Estimate of $238 million and our model estimate of $234 million. Oncology product sales rose 45% to $333.4 million. Chemotherapy drug Rylaze/Enrylaze posted sales of $103.7 million, up 10% year over year. This figure beat the Zacks Consensus Estimate and our model estimate, each pegged at $97 million. Zepzelca, approved for small-cell lung cancer (SCLC), recorded sales of $101 million, up 60% year over year. This upside was primarily driven by continued uptake of the drug in the recently approved front-line SCLC setting. Acute...

For the quarter ended March 2026, Jazz Pharmaceuticals (JAZZ) reported revenue of $1.07 billion, up 19.1% over the same period last year. EPS came in at $6.34, compared to $1.68 in the year-ago quarter. The reported revenue represents a surprise of +9.97% over the Zacks Consensus Estimate of $972 million. With the consensus EPS estimate being $4.67, the EPS surprise was +35.91%. While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street expectations to determine their next move, some key metrics always offer a more accurate picture of a company's financial health. As these metrics influence top- and bottom-line performance, comparing them to the year-ago numbers and what analysts estimated helps investors project a stock's price performance more accurately. Here is how Jazz performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts: Total revenues- Oncology- Total: $333.4 million versus the six-analyst average estimate of $283.7 million. The reported number represents a year-over-year change of +45.3%. Total revenues- Oncology- Defitelio/defibrotide: $47.4 million versus the five-analyst average estimate of $42.19 million. The reported number represents a year-over-year change of +16.6%. Total revenues- Neuroscience- Oxybate- Xywav: $408.2 million versus $369.95 million estimated by five analysts on average. Compared to the year-ago quarter, this number represents a +18.4% change. Total revenues- Neuroscience- Epidiolex/Epidyolex: $249.8 million compared to the $238.02 million average estimate based on five analysts. The reported number represents a change of +14.7% year over year. Total revenues- Neuroscience- Oxybate (Xywav & Xyrem): $439.4 million versus the five-analyst average estimate of $390.18 million. The reported number represents a year-over-year change of +15%. Total revenues- Oncology- Rylaze/Enrylaze: $103.7 million versus the five-analyst average estimate of $97.36 million. The reported number represents a year-over-year change of +10.1%. Total revenues- Oncology- Vyxeos: $26.6 million versus the five-analyst average estimate of $31.62 million. The reported number represents a year-over-year change of -10%. Total revenues- Oncology- Zepzelca: $101 million versus $76.2 million estimated by five analysts on average. Compared to the y...

Record Q1 performance: Jazz reported its highest-ever first-quarter revenue of about $1.1 billion (+19% YoY), generated over $400 million in cash flow, posted non-GAAP adjusted EPS of $6.34, and reaffirmed full-year 2026 revenue guidance of $4.25–$4.5 billion. Zanidatamab advances toward launch: The FDA accepted the supplemental BLA for Ziihera with priority review (PDUFA date Aug. 25, 2026) after HERIZON‑GEA‑01 triplet-arm data showed strong efficacy (median OS 26.4 months), and Jazz says it is ready to launch in first-line GEA upon approval. Pipeline catalysts and balance-sheet strength: Jazz expects ASCO presentations and interim overall‑survival readouts for zanidatamab mid‑year and a Modeyso OS readout later this year/early 2027, while sitting on roughly $2.9 billion in cash and pursuing business development amid growing oxybate generic competition. Interested in Jazz Pharmaceuticals PLC? Here are five stocks we like better. Zymeworks Offers Hope for More than Just Long-Term Investors Jazz Pharmaceuticals (NASDAQ:JAZZ) reported what executives repeatedly characterized as an exceptionally strong start to 2026, driven by double-digit growth across promoted brands and continued momentum from recent launches. On the company’s first-quarter earnings call, management also highlighted progress toward a potential label expansion for zanidatamab (Ziihera) in first-line gastroesophageal adenocarcinoma (GEA), along with upcoming clinical catalysts for Modeyso and additional zanidatamab studies. President and CEO Renée Gala said the company delivered its “highest ever first quarter total revenues of $1.1 billion,” representing more than 19% year-over-year growth, led by XYWAV, Epidiolex, Modeyso and Zepzelca. Gala also cited “cash flow of over $400 million in the first quarter” and non-GAAP adjusted EPS of $6.34. → Roblox Stock Slides to New Low as Safety Changes Weigh on Outlook Top Marijuana Stocks: Plenty of Investment Opportunities Abound (You're not Late to the Game) CFO Philip Johnson reported record first-quarter revenue of $1.07 billion on a non-GAAP adjusted basis, attributing performance to “45% growth in our oncology portfolio, 18% growth in XYWAV, and 15% growth in Epidiolex.” Johnson noted two factors that modestly boosted the reported growth rate: a 13th shipping week for U.S. oncology products versus 12 in the prior-year quarter (about 2 percentage p...

DUBLIN (AP) — DUBLIN (AP) — Jazz Pharmaceuticals PLC (JAZZ) on Tuesday reported first-quarter net income of $293.1 million. The Dublin-based company said it had net income of $4.43 per share. Earnings, adjusted for one-time gains and costs, were $6.34 per share. The results exceeded Wall Street expectations. The average estimate of eight analysts surveyed by Zacks Investment Research was for earnings of $4.67 per share. The drugmaker posted revenue of $1.07 billion in the period, also topping Street forecasts. Seven analysts surveyed by Zacks expected $972 million. Jazz expects full-year revenue in the range of $4.25 billion to $4.5 billion. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on JAZZ at https://www.zacks.com/ap/JAZZ

Jazz Pharmaceuticals (JAZZ) came out with quarterly earnings of $6.34 per share, beating the Zacks Consensus Estimate of $4.67 per share. This compares to earnings of $1.68 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +35.91%. A quarter ago, it was expected that this drugmaker would post earnings of $6.62 per share when it actually produced earnings of $6.64, delivering a surprise of +0.3%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Jazz, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $1.07 billion for the quarter ended March 2026, surpassing the Zacks Consensus Estimate by 9.97%. This compares to year-ago revenues of $897.84 million. The company has topped consensus revenue estimates three times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Jazz shares have added about 22.4% since the beginning of the year versus the S&P 500's gain of 5.2%. While Jazz has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Jazz was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stock...

Image source: The Motley Fool. May 5, 2026 at 4:30 p.m. ET President and Chief Executive Officer — Renée Galá Chief Commercial Officer — Samantha Pearce Chief Financial Officer — Philip L. Johnson Global Head of R&D and Chief Medical Officer — Robert Iannone Head of Investor Relations — John Bluth Need a quote from a Motley Fool analyst? Email [email protected] Operator: 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. John Bluth: 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 contained in these forward-looking statements. We encourage you to review these risks and uncertainties described in today's press release and under the caption Risk Factors in our annual report on Form 10-K for the fiscal year ended 12/31/2025. We undertake no duty or obligation to update our forward-looking statements. As noted on slide three, we will discuss non-GAAP financial measures on this webcast. Descriptio...

– Strong commercial execution across franchises with total revenues of $1.1 billion (+19% YoY) – – Zanidatamab HER2+ 1L GEA sBLA granted Priority Review; PDUFA date of August 25, 2026 – – Xywav® revenues grew 18% YoY with 425 net patient adds – – Epidiolex® revenues grew 15% YoY– – Company reaffirms 2026 revenue and expense guidance – DUBLIN, May 5, 2026 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced financial results for the first quarter of 2026 (1Q26). "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," said Renee Gala, president and chief executive officer of Jazz Pharmaceuticals. "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. Looking ahead, we are excited about the potential launch of zanidatamab in 1L GEA later this year, as we progress our pipeline and business development efforts to bring more life-changing therapies to patients and fuel durable long-term growth." Key First Quarter 2026 Highlights Total revenues in 1Q26 grew to $1.1 billion (+19% year-over-year (YoY)) Generated GAAP / non-GAAP1 adjusted earnings per share (EPS) of $4.43 / $6.34 with $408 million in cash from operations. Practice-changing Phase 3 HERIZON-GEA-01 results, presented as a late-breaker at ASCO GI, support zanidatamab as the HER2-targeted agent of choice in HER2+ 1L advanced gastroesophageal adenocarcinoma (GEA); additional benefit from tislelizumab irrespective of PD-L1 status. Supplemental Biologics License Application (sBLA) accepted by FDA under Real-Time Oncology Review (RTOR) program with potential approval and launch in 1L HER2+ GEA on or before PDUFA date. Business Updates Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution: Xywav net product sales increased 18% to $408 million in 1Q26, compared to 1Q25. Continued physician and patient demand for the differentiated benefits of low-sodium Xywav. Strong new patient growth, with approximately 425 net patient adds in 1Q26. There were approximately 16,600 active patients exiting the quarter, comprised of approximately 11,075 narcolepsy patients and approximately 5,525 idiopathic hypersom...