Jazz Pharmaceuticals PLC Q3 2024 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Jessica Fye - PMorgan Chase & Co - Analyst : Hey, guys. Good evening. Thanks for taking my question. I was just wondering on Xywav, can we think of the 150 net patient adds in narcolepsy as reproducible in the future? It's a big uptick from what we saw last quarter. So I'm curious how you're thinking about that. And if this might be the impact of the field nurse educator program helping with persistence in the early treatment phase? Thank you.

Question: Jason Gerberry - BofA Securities Inc - Analyst : Hey, guys. Thanks for taking my question. On Zepzelca, I'm wondering -- if you can kind of help us frame the reg past. Is this submission just on the Phase III result alone? Is there any implications to this Phase III [ Lagoon ] study being confirmatory? Or does the frontline data just kind of stand on its own, and it would be its own unique, I guess, indication? And thinking about the commercial opportunity. I mean, you haven't given detailed data, but presumably, you said it's clinically meaningful. So it's adding a few months of PFS. So should we just think about this as expanding the market about 7,000 patients and adding a couple of cycles of therapy. Is that the right way to be thinking about sort of the relative impact here?

Question: Marc Goodman - Leerink Partners LLC - Analyst : Yes. Hi. Can you give us your latest thoughts on the orexin class, the recent data releases from competition, how you're thinking about it? And what can you share about your product 441, -- any data that you can comment on any of the commentary on the adverse events that stopped you from working on this before. Just anything more you can tell us about your product as well? Thank you.

Question: Ami Fadia - Needham & Company LLC - Analyst : Hi, good evening. Thanks for taking my question. Just on the topic of zani. In GEA, you're conducting the Horizon 1 trial. Can you give us some sense of in the Phase 2 study, what percent of patients for PD-L1 positive versus negative and if you saw any difference in the efficacy results across the two subsets. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 06, 2024 / 9:30PM, JAZZ.OQ - Q3 2024 Jazz Pharmaceuticals PLC Earnings Call And just thinking about the (inaudible) trial. Maybe if you could just give some color on how -- I believe that Zymeworks had done some work before you guys took on zani in other cancer types. So how this basket trial and likely to be broader in kind of what areas it might be exploring? Thank you.

Question: David Amsellem - Piper Sandler Companies - Analyst : Thanks. So my question is also on Zepzelca. And specifically, I wanted to get your thoughts on the exclusivity runway for the products. So in the orange book, you've got a patent expiration in December of '29. And then you have Orphan Exclusivity expiring in '27. With the first-line data, do you expect to get an ODE on extensive Stage (inaudible) first line? How should we think about how your exclusivity runway may or may not change with the first-line data? Thank you.

Question: Andrea Newkirk - The Goldman Sachs Group Inc - Analyst : Thank you for taking our questions. I was just wondering here if you could provide more color on the pipeline prioritization that you mentioned? And how we should think about the makeup of the portfolio now. And then given these changes, how does that impact your appetite for potential BD transactions, whether it be in neuro versus oncology? Thanks so much.

Question: Michael Riad - Morgan Stanley - Analyst : Hi. This is Michael Riad on for Jeff Hung. Thank you for taking our question. Circling back to the discussion on the Orexin program. For the Phase 1b, do you have any additional color you could provide on the level of dose reduction you'd go for with 441 in Q1? And would there be like enough leeway to potentially accommodate expanding to other types of narcolepsy or IH? Thanks so much.

Question: Joon Lee - Truist Securities - Analyst : Hey. Thanks for taking our questions. It's nice to see the growth of EBITDA like six years since the launch, how much of it is geographic expansion versus greater penetration? And for the former, what gives you confidence in approval in Japan. And for the latter, -- is there a particular segment or line of use within epilepsy that's driving growth? Thank you.

Question: Gary Nachman - Raymond James Financial Inc - Analyst : Hi. Good afternoon. Just following up on oncology. So specifically, with Rylaze, just talk about your initiatives to expand more in AYA. And has anything changed and where you see the peak potential for that opportunity? And then also, Defitelio was noticeably higher in the third quarter. So anything worth highlighting there just if that's durable going forward? Thanks.