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.
First-quarter results: record revenue, strong cash flow, and reaffirmed guidance
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.
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 points of worldwide growth), and foreign exchange tailwinds from a weaker U.S. dollar (about 1.5 percentage points).
On expenses, Johnson said non-GAAP adjusted SG&A declined year over year due largely to $172 million in litigation settlement expenses recorded in the prior-year quarter. Excluding that item, SG&A rose $8 million, “driven by the inclusion of Modeyso expenses.” Non-GAAP adjusted R&D increased $13 million, which Johnson tied to Modeyso trial costs and higher compensation-related expense.
Johnson said the company is reaffirming its full-year 2026 guidance, including total revenue guidance of $4.25 billion to $4.5 billion. He also reiterated expectations for heightened competition in the sleep market in the back half of the year, including “high sodium generics gaining volume” and the possible entry of “one or more daytime wake-promoting agents” in narcolepsy, alongside declines in XYREM and authorized generic revenue as high-sodium oxybate generics expand.
Commercial performance: growth across sleep, epilepsy, and oncology brands
Chief Commercial Officer Samantha Pearce outlined broad-based first-quarter growth across Jazz’s portfolio.
- XYWAV: Net product sales increased 18% to $408 million. Pearce said the brand added approximately 425 net patients in the quarter and ended with about 16,600 active patients. She said most net adds continued to come from idiopathic hypersomnia (IH), with “300 net patient adds for IH.” Pearce emphasized that XYWAV remains “the only FDA-approved treatment for idiopathic hypersomnia.”
- Epidiolex: Net product sales increased 15% to $250 million, driven by 16% volume growth. Pearce said expanding use in adult patients, “specifically in the long-term care setting,” remains a key growth opportunity. She also highlighted the impact of the company’s Nurse Navigator program on persistency and said Jazz partnered with Nippon Zoki for regulatory, distribution, and commercial activities in Japan while Jazz remains the clinical trial sponsor.
- Ziihera: Net product sales were $13 million in the quarter. Pearce said feedback from biliary tract cancer (BTC) physicians has been positive and that the company is expanding beyond academic centers into community accounts while preparing for a potential GEA launch.
- Modeyso: First-quarter net product sales were $41 million, following an August 2025 launch. Pearce said approximately 500 patients have been treated since launch through quarter end. In Q&A, Pearce said early launch performance increases confidence in “achieving that $500 million peak opportunity in the U.S.” She added that the company’s population estimates remain aligned with historical ranges discussed by an analyst, while noting potential upside from longer treatment duration than initially anticipated.
- Zepzelca: Net product sales rose 60% to $101 million, which Pearce attributed primarily to uptake in the front-line maintenance setting after an October FDA approval for Zepzelca in combination with Tecfidera. Pearce said the company expects first-line maintenance adoption to grow through 2026, while second-line use declines due to competition and fewer treatment-naïve patients.
Pearce also discussed Rylaze, which posted $104 million in revenue, up 10% year over year. She said the comparison was against a “quite a low Q1 2025,” and described roughly $100 million per quarter as “a good kind of stable base for us currently.”
Zanidatamab in GEA: priority review and launch preparation
Management focused heavily on advancing zanidatamab in first-line locally advanced or metastatic GEA. Gala said the FDA accepted the supplemental BLA for Ziihera under Real-Time Oncology Review and granted priority review with a PDUFA date of Aug. 25, 2026. She said the company is ready to launch in GEA “as soon as we receive FDA approval.”
Global Head of R&D and Chief Medical Officer Robert Iannone pointed to HERIZON-GEA-01 trial data, saying zanidatamab “offers improved outcomes on all efficacy measures compared to trastuzumab.” He highlighted results from the triplet arm of zanidatamab, tislelizumab, and chemotherapy, including median overall survival of 26.4 months and a median duration of response of 20.7 months among responders, with benefits observed irrespective of PD-L1 status. Iannone attributed potential synergy to zanidatamab’s “biparatopic binding” mechanism, which can cluster HER2 receptors and trigger immune activation.
Pearce said physicians have expressed “excitement and interest” in potential use in GEA, adding that it has been “more than 15 years since a new first-line HER2-targeted agent became available” for metastatic gastric cancer. She also emphasized operational readiness, noting “approximately 90% overlap between BTC and GEA accounts,” an existing permanent J-code from the BTC approval, and JazzCares support services to facilitate access at launch.
Pipeline and upcoming catalysts: interim analyses and additional trials
Iannone said Jazz expects to present additional data at ASCO in early June, including presentations on lerodectide and zanidatamab. He also said the “second planned interim analysis for overall survival” for the zanidatamab-plus-chemotherapy arm of HERIZON-GEA remains expected mid-year.
For zanidatamab in metastatic breast cancer, Iannone said enrollment is progressing in the phase III EmpowHER trial in patients who have progressed on or are intolerant to ENHERTU, with enrollment expected to complete in the first half of 2027 and top-line data anticipated in late 2027 or early 2028. In response to an analyst question on sequencing post-ENHERTU, Iannone said Jazz’s trial would be the first randomized study to “definitively” evaluate zanidatamab versus standard of care in that setting, aiming to provide data to inform treatment decisions.
On Modeyso, Iannone said Jazz expects an interim overall survival readout from the phase III ACTION trial “later this year or early 2027.” During Q&A, he emphasized the trial is event-driven and includes “one interim analysis and then a final analysis,” with timing dependent on the pace of events.
Competitive dynamics, IP updates, and business development priorities
In Q&A, executives addressed competitive dynamics in the oxybate market. Pearce said two multi-source generics entered the market in the first quarter, but the company has not yet seen an impact on XYWAV. She added that Jazz anticipates generics may gain volume through the year and that payers may introduce utilization management, though the company does not yet know the extent. Johnson also pointed to first-quarter reauthorization dynamics and said some net price benefit came from gross-to-net favorability and faster transitions back onto insurance, which he described as more of a first-quarter phenomenon.
Gala said Jazz remains confident in its patent estate for the oxybate franchise, citing Orange Book-listed patents “out to 2033 and 2037,” and an IH-related Orange Book-listed patent “out to 2041.” Iannone said the company believes orexin therapies are likely to be complementary to oxybates, arguing that oxybates are the only therapy that directly addresses disrupted nighttime sleep.
On Zepzelca intellectual property, Gala said Jazz has multiple patents extending to 2040 and is pursuing additional patents related to combinations, formulations, and methods of treatment. She also said the company has filed suit against five ANDA filers, which she said triggered an FDA stay of approval “for up to the 30 months.”
Turning to business development, Gala said Jazz is “highly engaged” and expects to announce deals over the course of the year. She described a strategy focused on rare disease, including strengthening positions in sleep, epilepsy, and rare oncology and expanding into new rare disease areas. Gala said the company is looking at both licensing structures and outright M&A, and cited Jazz’s financial position—$2.9 billion in cash and investments at quarter end and $408 million of cash from operations in the first quarter—as providing flexibility.
About Jazz Pharmaceuticals NASDAQ: JAZZ
Jazz Pharmaceuticals plc is a global biopharmaceutical company focused on developing and commercializing therapies in neuroscience and oncology. The company's research and development efforts target unmet medical needs in sleep disorders, hematologic malignancies, rare neurological conditions and solid tumors. Jazz's product portfolio includes therapies for narcolepsy, hepatic veno-occlusive disease, acute myeloid leukemia and other serious disorders.
Flagship products from Jazz Pharmaceuticals include Xyrem® (sodium oxybate) and Xywav® (calcium, magnesium, potassium, and sodium oxybates) for the treatment of cataplexy and excessive daytime sleepiness in patients with narcolepsy.
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