Jazz Pharmaceuticals (JAZZ) Q1 FY26 earnings call: guidance and Q&A

How will physicians sequence HER2 agents if zanidatamab is approved post-HER2, given the lack of data for other products in this setting?

The EmpowHER trial (303) is designed to definitively evaluate zanidatamab against standard of care in a randomized setting, providing crucial data for sequencing decisions where current data is limited.

“The trial that we're running 303 will be the first time that we definitively in a randomized setting, evaluate zanidatamab versus what would be considered a standard of care. So we expect to be out ahead with important data that will inform decisions about whether to use zanidatamab or other HER2 agents in that space.”

asked by Jess Fye · answered by Robert Iannone

What are the updated thoughts on Modeyso's patient population size given strong launch, and what is Jazz's M&A sweet spot?

Modeyso's strong launch (500 patients treated, $41M Q1 sales) supports the $500M peak opportunity, with potential upsides in treatment duration. Jazz is highly engaged in BD, focusing on rare diseases (epilepsy, sleep, rare oncology) and new rare disease areas, looking at licensing, structured deals, and M&A, leveraging its strong financial position.

“We are highly engaged on the BD front, and I do expect us to have deals announced over the course of this year. We do have a clear strategy that is focused on expanding our presence in rare disease, in particular, where we believe there's a significant unmet need.”

asked by Joseph Thome · answered by Samantha Pearce

How is Jazz thinking about its continued focus on epilepsy, given multiple assets (Epidiolex, JZP-047) and potential BD, regarding synergies or cannibalization?

Epilepsy remains a key focus due to significant unmet need and polypharmacy. Jazz sees ample room for new mechanisms and options, building scale around Epidiolex's long durability. They are investing in internal R&D for novel mechanisms and are excited about future opportunities without significant cannibalization concerns.

“We think with the position that we have with Epidiolex being the #1 branded product and having the very long durability out to the very late 2030s, it gives us greater opportunity to continue to build around that franchise to build scale.”

asked by Leonid Timashev · answered by Renée Galá

How significant is the potential move of Modeyso into first-line treatment, similar to Zepzelca's inflection, in terms of market expansion or duration?

Moving Modeyso to first-line treatment (ACTION study) would expand the market by treating more patients who might not reach second-line, and increase treatment duration by starting therapy earlier. These factors contribute to achieving the $500 million peak potential.

“Some patients don't make it to second line. So of course, there are more patients available to be treated. But having the opportunity to get Modeyso to patients before they progress will mean that the duration of treatment should be longer if they can use it straight after radiation.”

asked by Annabel Samimy · answered by Samantha Pearce

What drove Epidiolex's strong OUS performance, and what's the outlook for Rylaze after a good quarter?

Epidiolex OUS growth was primarily volume-driven (2/3) with some FX and gross-to-net benefits (1/3), reflecting strong execution and continued penetration. Rylaze's $104 million quarter was strong but compared to a low Q1 '25; the COGS impact is fully realized, and $100 million per quarter is a stable base.

“Around about 2/3 of that, I believe, was volume, and there was about 1/3 due to FX and some gross to net benefits from places like the U.K. with a VPAG adjustment that happened there.”

asked by Marc Goodman · answered by Samantha Pearce

Can you elaborate on second-half dynamics for oxybates, potential competitive pressure from LUMRYZ, and perceived pressure to IH growth?

Xywav maintains strong momentum with 425 net patient adds (300 IH) and strong payer coverage. While generics are expected to build volume in H2, Xywav's low-sodium formulation, IH approval, and nighttime efficacy are key differentiators. LUMRYZ's net patient adds are lower than Xywav's narcolepsy adds, underscoring Xywav's unique benefits.

“I think LUMRYZ net patient adds were announced roughly 100 adds this quarter, like the 100 last quarter. Our numbers just in narcolepsy have been larger than that in each of those 2 quarters.”

asked by Jordan Becker · answered by Samantha Pearce

How should we think about the life of Zepzelca beyond the 2029 compound of matter patent, given new Orange Book listed patents extending to 2040?

Jazz has a strong patent estate for Zepzelca, with multiple patents extending to 2040. They are pursuing additional new patents (combo therapies, formulations, methods of treatment). Lawsuits have been filed against all 5 ANDA filers, resulting in a 30-month stay of approval, indicating confidence in their IP.

“So we do have a strong patent estate for Zepzelca. And as you noted, we do have multiple patents that extend out to 2040. We're also pursuing multiple new patents with the patent office that would also extend out to that time frame with additional applications, whether that be combo therapies, formulations, or methods of treatment.”

asked by Mohit Bansal · answered by Renée Galá